PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network 429745-7 INGEVITY Active Fixation and Passive Fixation Pace/Sense Lead Study MacGregor, John Cardiac Pacemakers, Inc. DBABoston Scientific Cardiac Rhythm Management NCT01688843; IDE# 110227 Active 9/4/2015 Northwest 504829-1 Multi-Institutional Registry for Prostate Cancer Radiosurgery (RPCR) Myers, Michael Florida Robotic Radiosurgery Association NCT01226004 Active Open to Enrollment 8/30/2015 Columbia 429636-7 Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): A Randomized Trial McEvoy, Cindy NIH - 2nd NCT01723696 Active Open to Enrollment 9/4/2015 Columbia 429747-5 The THERAPY Trial: The Randomized Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke Hauck, Erik Penumbra, Inc. NCT01429350; IDE# G110099 Active 8/30/2015 Oregon West 429714-3 HDE: Spiration IBV Valve System - HDE #H060002 Ameen, Khuram Spiration, Inc. NCT01166516; HDE#H060002 Active 9/23/2015 Oregon West UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES Sponsor Project Status Project Expiration Date Title 429677-4 RTOG 0413: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage O, I, II Breast Cancer Taylor, Michael RTOG NCT00103181 Active Data Analysis Only 8/16/2015 Northwest 429646-2 Onyx(R) Liquid Embolic System (Onyx(R) HD-500) - HDE# H060003 Shanno, George Ev3 Neurovascular HDE#H060003 Active 8/30/2015 Columbia 429719-5 RTOG 0815: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer Taylor, Michael RTOG NCT00936390 Active 9/4/2015 Northwest 429678-3 The AOSSM Multi-Center ACL Revision Study (MARS) Lantz, Brick AOSSM NCT00625885 Active 9/21/2015 Oregon West 429701-6 CYPRESS: A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual AntiPlatelet Therapy (DAPT) in Subjects Undergoing Cook, Stephen Cordis Corporation NCT00954707; IDE G080186 Active 9/15/2015 Oregon West UPDATED 9/30/2014 PI Name Board Reference Number IRBNet ID Network PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network Percutaneous Coronary intervention with the CYPHER Sirolimus-Eluting Coronary Stent (CYPHER Stent) 429746-3 Breast Cancer Markers in Human Tears: Development of a MALDI Based Mass Spectrometry Assay of Tears to identify Early Stage Breast Cancer Piniewski, Brigitte 429731-3 Pilot Dissemination of an Eating Disorder Prevention Program in Pediatric Care Linnville, Deanna 429703-3 HDE: The ENTERPRISE Vascular Reconstruction Device and Delivery System (HDE #H060001) Hauck, Erik 429704-5 HDE: The Neuroform Microdelivery Stent System HDE #H020002 429630-3 Mechanisms of Sudden Cardiac Death Study UPDATED 9/30/2014 Ascendant Diagnostics and PeaceHealth Laboratories No NCT Active 10/8/2015 Columbia No NCT Active 10/27/2014 Oregon West Cordis No NCT Active 8/30/2015 Oregon West Hauck, Erik Stryker Corporation No NCT Active 8/30/2015 Oregon West Chugh, Sumeet NIH - 2nd No NCT Active Open to Enrollment 11/14/2014 Columbia PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name 527657-2 Connect MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry Nestor, Patrick 523335-1 Effects of pharmacist interventions on adherence to oral chemotherapy 528942-1 Sponsor Project Status Project Expiration Date Network NCT1688011 Active 11/17/2014 Northwest Reynolds, Diana No NCT Active Open to Enrollment 11/19/2014 Northwest Implementation and evaluation of a discharge pharmacy service at a community hospital Chang, Lydia No NCT Active Open to Enrollment 11/19/2014 Columbia 429651-3 Wingspan(R) Stent System with Gateway(R) PTA Balloon Catheter, Humanitarian Use Device - HDE #H050001 Shanno, George Stryker HDE H950001 Active Open to Enrollment 11/19/2014 Columbia 429660-3 SECURE-C Cervical Artificial Disc Postmarket Approval Study Le, Hoang Globus Medical NCT00882661; PMA# P100003 Active Closed to Enrollment 11/19/2014 Columbia 429639-3 Codman Enterprise Vascular Reconstruction Device and Delivery System - HDE #H060001 Shanno, George Codman Enterprise (J&J) HDE H060001 Active 11/19/2014 Columbia 429661-3 Comparative Effectiveness Research Study of Peripheral KarmyJones, Riyad SORCE/SCOA P Grant NCT01378260 Active Open to 11/19/2014 Columbia UPDATED 9/30/2014 Celgene Board Reference Number PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Arterial Disease (PAD) Project Status Project Expiration Date Network Enrollment 429654-5 Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the treatment of Critical Limb Ischemia due to Peripheral Arterial Occlusive Disease Teso, Desarom Harvest Technologies NCT01245335; IDE 13110 Active 11/19/2014 Columbia 429749-3 A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke Hauck, Erik Penumbra, Inc. NCT01584609; IDE# G120028/S003 Active 11/20/2014 Oregon West 517203-1 Enhancement of FAST Spect Myocardial Perfusion Imaging Fish, Mathews PeaceHealth No NCT Active 11/20/2014 Oregon West 429645-3 Neuroform Microdelivery Stent System - HDE #H020002 Shanno, George Stryker HDE H020002 Active 11/20/2014 Columbia 429679-3 Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolation Using the Atricure McClelland, James Atricure, Inc. NCT00566176; IDE# Active 11/20/2014 Oregon West UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation Board Reference Number Project Status Project Expiration Date Network G050028/S002 429718-2 Prediction of Susceptibility to Acute Mountain Sickness Using Hypoxia-Induced Intrapulmonary Arteriovenous Shunt and Intracardiac Shunt Fractions Lovering, Andrew Department of Defense No NCT Active 12/5/2014 Oregon West 429722-10 RTOG 1010 A Phase III Trial Evaluating the Addition of Trastuzumub to Trimodality Treatment of HEr2Overexpressing Esophageal Adenocarcinoma Taylor, Michael RTOG NCT01196390; IND# 108220 Active 12/14/2014 Northwest 495134-2 Pilot Evaluation of an ACT Intervention for Patients with Cardiovascular Disease Biglan, Anthony Oregon Research Institute No NCT Active 12/16/2014 Oregon West 429644-2 JOSTENT GraftMaster Coronary Stent Graft and Delivery System HDE #H000001 Kozinski, Margo Abbott Vascular HDE H000001 Active Open to Enrollment 1/4/2015 Columbia 551187-2 Mechanistic approach to preventing atrophy and restoring function in older adults Dreyer, Hans National Institute on Aging NCT02145949 Deferred Information Required 1/9/2015 Oregon West UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES Sponsor Project Status Project Expiration Date Title 429735-7 ICY-AVNRT - Intracardiac CrYoablation for Atrio Ventricular Nodal Reentrant Tachycardia IDE # G100272 Reddy, Ramakota Medtronic NCT01426425; IDE# G100272 Active 1/9/2015 Oregon West 429634-3 Stenting and Angioplasty with Protection in Patients at HighRisk for Endarterectomy (SAPPHIRE Registry) Shanno, George Cordis, Corp. NCT00231270 Active 1/14/2015 Columbia 429635-3 Treatment of Primary and Metastatic Liver Tumors with TheraSphere (YTTRIUM-90 GLASS MICROSPHERES) - HDE #H960008 Bloch, Robert Cordis Corp. HDE H960008 Active Open to Enrollment 1/14/2015 Columbia 429738-4 CANOPY - Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy Coletti, Andrew Abbott Vascular NCT01445613 Active 1/15/2015 Northwest 429723-5 Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360 Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II) Beglin, Peter Cardiovascular System, Inc. NCT01092416; IDE G090106 Active 1/16/2015 Northwest UPDATED 9/30/2014 PI Name Board Reference Number IRBNet ID Network PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network 429751-2 The MIRACLE EF Study is a Prospective, Randomized, Controlled, Double-Blinded, Global, Multi-Center Cardiac Resynchronization Therapy (CRT) in Heart Failure clinical Study Reddy, Ramakota Medtronic, Inc. NCT01735916; IDE# G110223 S001 Active 1/25/2015 Oregon West 429672-2 RTOG 0247 Randomized Phase II Trial of Neoadjuvant Combined Modality Therapy for Locally Advanced Rectal Cancer Taylor, Michael Radiation Therapy Oncology Group NCT00081289 Active 1/25/2015 Northwest 429707-3 Connect CLL, The Chronic Lymphocytic Leukemia Disease Registry Nestor, Patrick Celgene Corporation NCT01081015 Active 1/25/2015 Northwest 429692-5 RTOG 0813: Seamless Phase I/II Study of Stereo-tactic Lung Radiotherapy (SBRT) for Early Stage Centrally Located NonSmall Cell Lung Cancer (NSCLC) in Medically Inoperable Patients Taylor, Michael Radiation Therapy Oncology Group NCT00750269 Active 1/25/2015 Northwest 429673-3 RTOG 0234 A Phase II Randomized Trial of Surgery Followed by Chemoradiotherapy Plus C225 (Cetuximab) for Advanced Squamous Cell Carcinoma of the Head and Neck Taylor, Michael Radiation Therapy Oncology Group NCT00084318 Active 1/25/2015 Northwest UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES Board Reference Number Project Status Project Expiration Date IRBNet ID Title PI Name Sponsor 429698-3 Muscle Regrowth during Physical Rehabilitation and Amino Acid Supplementation Dreyer, Hans C. UofO Dept Human Physiology/Slo cum Research & Education Foundation NCT00760383 Active 2/6/2015 Oregon West 429732-3 A Family Caregiver Protocol to Reduce Hospital Readmissions Coleman, Eric Gordon and Betty Moore Foundation No NCT Active 2/16/2015 Oregon West 429647-4 Patient and Partner Intervention to Improve Outcomes after an Implantable Cardioverter Defibrillator (ICD) Bradshaw, Kieth (Mic) NIH - 2nd NCT01252615 Active 2/16/2015 Columbia 429671-9 HDE JOSTENT Coronary Stent Graft Coletti, Andrew Abbott Vascular No NCT Active 2/19/2015 Northwest 563620-4 INTERMACS Smith, Cristy NCT00119834 Active 2/20/2015 Northwest 429708-3 SKTA iWell21 Clinical Trial Protocol Piniewski, Brigitte NCT01325376 Active 2/22/2015 Oregon West 563635-4 OPEN CTO Lombardi, William NCT 02026466 Active Open to Enrollment 3/2/2015 Northwest UPDATED 9/30/2014 SKTA Network PEACEHEALTH SYSTEM IRB APPROVED STUDIES Sponsor Project Status Project Expiration Date Title 429706-3 (TRAP) Quantification of Exercise-Induced Intrapulmonary Arteriovenous Shunt in Human Subjects Breathing Normoxia, Hypoxia, and Hyperoxia Lovering, Andrew U of O Department of Physiology No NCT Active Open to Enrollment 3/6/2015 Oregon West 429643-3 Improving Prehospital Trauma Triage: Generating a CostEffective and Resource-Efficient Mechanism for the Field Triage of Injured Persons (Registry) Newgard, Craig Robert Wood Johnson Foundation No NCT Active 3/6/2015 Columbia 440188-21 Improving Care and Reducing Cost (ICRC) Brasted, Robert Center for Medicaid and Medicare Services (CMS) No NCT Active 3/6/2015 Oregon West 439157-3 OPEN CTO - Outcomes, Patient health status, and efficiency in chronic Total Occlusion hybrid procedures Cook, Stephen St. Luke's NCT 02026466 Active Open to Enrollment 3/13/2015 Oregon West 429663-5 S-ICD System Post Approval Study (S-ICD PAS) Swenson, Robert Boston Scientific NCT01736618 Active Open to Enrollment 3/13/2015 Columbia 429667-6 HDE: JOMED JOSTENT Coronary Stent Graft Cook, Stephen JOMED No NCT Active 4/15/2015 Oregon West UPDATED 9/30/2014 PI Name Board Reference Number IRBNet ID Network PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network 429726-9 RTOG 1016 Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer Taylor, Michael RTOG NCT01302834 Active 4/15/2015 Northwest 429666-4 HDE Ascension PIP Finger Implant, HDE# H010005 Blackburn, James Ascension No NCT Active 4/15/2015 Northwest 429740-9 Comparative Effectiveness research Study of Peripheral Arterial Disease (PAD) Flum, Dave Agency for Healthcare Research and Quality NCT01378260 Active Closed to Enrollment 4/15/2015 Northwest 435256-7 GLORIA-AF Global Registry on Long Term Oral Anti-thrombotic treatment in Patients with Atrial Fibrillation Munkenbeck, Frances Boehringer Ingelheim NCT01468701 Active 5/8/2015 Oregon West 429676-4 The ResQ Trial: Comparison of Standard Cardiopulmonary Resuscitation (S-CPR) Alone Versus Active Compression Decompression Cardiopulmonary Resuscitation (ACD-CPR) Plus an Inspiratory Impedance Threshold Device (ITD) Versus SCPR Plus an ITD on Survival From Out-of-Hospital Cardiac Arrest Wayne, Marvin NIH, Advanced Circulatory Systems, Inc. NCT00189423 Active Data Analysis Only 5/15/2015 Northwest UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network 429727-11 EXPERT CTO: Evaluation of the XIENCE V Coronary Stent, Performance and Technique in Chronic Total Occlusions Beglin, Peter Abbott Vascular NCT01435031, IDE# G110103 Active Closed to Enrollment 5/27/2015 Northwest 429725-9 Longitudinal Surveillance Registry of the ACUITY Spiral Lead MacGregor, John Cardiac Pacemakers, Inc. DBABoston Scientific Cardiac Rhythm Management NCT00955708 Active 6/1/2015 Northwest 433177-8 ABSORB RANDOMIZED CONTROLLED TRIAL: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions (Protocol 10-392) Lombardi, William Abbott Vascular NCT01751906; IDE# G120002 Active 6/5/2015 Northwest UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number NCT00202878; PMA# P04103 429664-18 A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Table) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes; Vytorin Efficacy International Trial IMPROVE IT) Lombardi, William Merck Sharp & Dohme Corp. 429649-3 Resuscitation Outcomes Consortium (ROC) (Epistry/Registry) Newgard, Craig National Heart, Lung, and Blood Institute (NHLBI) 429631-4 Prospective evaluation of CyberKnife(R) Stereotactic Radiosurgery for low and intermediate risk Prostate Cancer Pukel, Clifford Accuray, Inc. 429633-5 Field Trial of Hypotensive Resuscitation versus Standard Resuscitation in Patients with Hemorrhagic Shock After Trauma, A Pilot Trial KarmyJones, Riyad NIH - 2nd UPDATED 9/30/2014 Project Status Project Expiration Date Network Active Closed to Enrollment 6/5/2015 Northwest Active 6/11/2015 Columbia NCT00643994; 510(k) number K011024 Active 6/11/2015 Columbia NCT01411852 Active Closed to Enrollment 6/11/2015 Columbia PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network (HypoResus) 429699-3 Connect MM: The Multiple Myeloma Disease Registry Nestor, Patrick Celgene Corporation 429648-3 Prospective Validation and Cost Analysis of the National Guidelines for Field Triage (Chart Review) Newgard, Craig CDC 429712-7 A Multicenter, randomized, clinical outcome of VISIONAIRE Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty (Prot. ID# VISSTD01) Lantz, Brick Smith & Nephew 429669-3 Clinical Investigational Plan: Mainstream and Sidestream Capnography Sensors Coulombe, Rosa Respironics Novametrix, LLC 626271-1 The relationship between overlapping tourniquet time and the morbidity and mortality of simultaneous bilateral total knee Shah, Steven Slocum Research & Education Foundation UPDATED 9/30/2014 NCT01081028 Active 6/11/2015 Northwest Active Data Analysis Only 6/22/2015 Columbia NCT01084772 Active Closed to Enrollment 6/22/2015 Oregon West No NCT Active 6/26/2015 Oregon West Active 7/5/2015 Oregon West PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network arthroplasty. 486295-6 In-Utero Smoke, Vitamin C, and Newborn Lung Function McEvoy, Cindy National Institutes of Health NCT00632476 Active Closed to Enrollment 7/5/2015 Columbia 581412-4 Chronic Kidney Disease Outcomes and Practice Patterns Study Smith, Christine Arbor Research Collaborative for Health No NCT Active Open to Enrollment 7/5/2015 Northwest 427089-2 AI/AN Patient and Provider Perceptions of Surgical Cancer Care Flum, David National Cancer Institute No NCT Active 7/7/2015 Northwest 429641-3 Endovascular vs Open Repair of Traumatic Aortic Injuries: A MultiInstitutional Western Trauma Association Study (Registry) KarmyJones, Riyad Western Trauma Assoc. No NCT Active 7/10/2015 Columbia 479951-9 ABSORB III -Randomized Controlled Trial. A clinical evaluation of Absorb™BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions Gory, Dennis Abbott Vascular NCT01751906 Active 7/10/2015 Oregon West UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network 429693-5 Ischemia Reperfusion Injury during Total Knee Replacement (TKR) Surgery Dreyer, Hans C. NICHHD/NCM RR No NCT Active 7/10/2015 Oregon West 429705-12 RA1SE - Recovery After an Initial Schizophrenia Episode Brasted, Robert NIMH NCT01321177 Active 7/10/2015 Oregon West 585081-2 Navigate X4 MacGregor, John Boston Scientific NCT02071173; IDE G130222 Active Open to Enrollment 7/10/2015 Northwest 429632-8 Amiodarone (PM101), Lidocaine or Neither for Out-of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS: Amiodarone, Lidocaine or Placebo Study) Daya, Mohamud NIH - 2nd NCT01401647; IND 72383 Active Open to Enrollment 7/10/2015 Columbia 471453-1 NATRELLE® 410 X-Style and LStyle Breast Implants Continued Access Study Gabriel, Allen Allergan NCT01870869 Active 6/18/2016 Columbia 634929 A Multicenter, Multinational, Phase II Study to Evaluate Pertuzumab in Combination with Trastuzumab and Standard Neoadjuvant Sntracycline-Based Chemotherapy in Patients with HER2-Positive, Locally Crews, Jennie F. Hoffman-La Roche Ltd NCT02132949; IND #9900 Active 9/4/2015 Northwest UPDATED 9/30/2014 PEACEHEALTH SYSTEM IRB APPROVED STUDIES IRBNet ID Title PI Name Sponsor Board Reference Number Project Status Project Expiration Date Network Advanced, Inflammatory, or Early Stage Breast Cancer 612990 Examining the association between patient activation and cost, utilization and outcomes among patients with common orthopedic procedures. UPDATED 9/30/2014 Tavakolian, Jason Slocum Foundation & the PacificSource Charitable Fund Active 7/29/2015 Oregon West
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