10 completed, 3 terminated, 1 recruiting, 1 unknown. 8 Not applicable, 5 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Completed 4, Terminated 2, Recruiting 1, Withdrawn 1 |
| Phase 2 | 5 | Completed 5 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The RESET System Pivotal Clinical Trial (Protocol Revision K) RESET Liner, Sham - Diabetes type2, Obesity | Not applicable | Recruiting | Morphic Medical Inc. | 264 | 2019-09-09 | 2026-10-13 |
| EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects EndoBarrier SANS - Obesity, Type 2 Diabetes | Not applicable | Terminated | Morphic Medical Inc. | 7 | 2015-05-01 | 2016-02-10 |
| An Open-Label Extension to Protocol 09-1, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System EndoBarrier - Type 2 Diabetes | Not applicable | Withdrawn | Morphic Medical Inc. | 2015-04-01 | 2016-09-14 | |
| EndoBarrier Register Deutschland-Safety and Efficacy of the Endoscopic Duodenal-Jejunal Bypass Sleeve Insertion of EndoBarrier for approximately one year - Obesity, Diabetes Mellitus | Unknown | Universitätsklinikum Hamburg-Eppendorf | 1000 | 2014-01-01 | 2017-06-23 | |
| Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese EndoBarrier, Sham Procedure - Type 2 Diabetes, Obesity | Not applicable | Terminated | Morphic Medical Inc. | 325 | 2012-12-01 | 2017-02-01 |
| Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity EndoBarrier Gastrointestinal Liner - Type 2 Diabetes, Obesity | Terminated | Morphic Medical Inc. | 244 | 2010-12-01 | 2017-03-07 | |
| Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner EndoBarrier Gastrointestinal Liner - Type 2 Diabetes, Obesity | Not applicable | Completed | Morphic Medical Inc. | 45 | 2010-10-01 | 2017-04-24 |
| Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner Endobarrier Liner - Obesity | Phase 2 | Completed | Morphic Medical Inc. | 19 | 2010-09-01 | 2017-02-15 |
| Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study EndoBarrier Liner - Type 2 Diabetes | Not applicable | Completed | Morphic Medical Inc. | 23 | 2010-06-01 | 2017-02-17 |
| Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity EndoBarrier, Diet + Lifestyle Counseling - Type II Diabetes | Not applicable | Completed | Morphic Medical Inc. | 77 | 2009-10-01 | 2016-10-03 |
| A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics Type 2 Diabetes | Completed | Morphic Medical Inc. | 50 | 2009-09-01 | 2011-08-08 | |
| Study for Pre-Surgical Weight Loss in Type II Diabetes Patients GI Liner - Type 2 Diabetes, Obesity | Phase 2 | Completed | Morphic Medical Inc. | 22 | 2008-10-01 | 2017-06-01 |
| Study for Short Term Weight Loss in Candidates for Bariatric Surgery Endobarrier Liner - Obesity | Phase 2 | Completed | Morphic Medical Inc. | 46 | 2008-10-01 | 2016-09-15 |
| Multi-Center Pre-Bariatric Weight Loss Study GI Sleeve Implantable weight loss device (EndoBarrier), Sham Procedure - Obesity | Phase 2 | Completed | Morphic Medical Inc. | 56 | 2007-06-01 | 2017-02-15 |
| A Study of the GI Sleeve for the Treatment of Type 2 Diabetes EndoBarrier Gastrointestinal Liner, Sham: endoscopy and standard of care - Type 2 Diabetes | Phase 1 / Phase 2 | Completed | Morphic Medical Inc. | 36 | 2007-01-01 | 2016-12-28 |
| A Multicenter Study for Pre-Surgical Weight Loss EndoBarrier Device, Diet & Lifestyle Counseling - Obesity | Not applicable | Completed | Morphic Medical Inc. | 43 | 2007-01-01 | 2017-05-17 |
Obesity (12) · Diabetes Mellitus, Type 2 (11) · Diabetes Mellitus (2) · Weight Loss (2)
Diet (2) · salicylhydroxamic acid (2) · Standard of Care (1)
Chile (3) · United States (3) · Brazil (2) · Netherlands (2) · Germany (1) · Malaysia (1) · United Kingdom (1)
Alex P Escalona, MD (2) · Jan Willem Greve, MD (2) · Keith Gersin, MD (2) · Alex Escalona, MD (1) · Christopher C Thompson, MD (1) · Eng Hong Pok, MD (1) · Jens Aberle (1) · Julian Teare, MD (1) · Lee M Kaplan, MD, PhD (1) · Leonardo Rodriguez Grunert, MD (1) · Michael Tarnoff, MD (1) · Ricardo Cohen, MD (1) · Wah Kheong Chan, MD (1)
PMID 19858703, PMID 21932999, PMID 22534421, PMID 23920034, PMID 25072436, PMID 26446491, PMID 29504053