Phase 2 N=56 Randomized Single-blind Treatment

Multi-Center Pre-Bariatric Weight Loss Study

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00469391 ↗

Enrolled (actual)

Serious AEs

4.3%

Results posted

Dec 2016

Primary outcome: Primary: Percent Excess Weight Loss (%EWL) at Week 12 — 11.9; 2.7 Percentage of Excess Weight Loss

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: GI Sleeve Implantable weight loss device (EndoBarrier) (Device); Sham Procedure (Procedure)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Morphic Medical Inc.
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Excess Weight Loss (%EWL) at Week 12	11.9; 2.7	—

Summary

The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

Eligibility Criteria

Inclusion Criteria

BMI > 35 with a significant comorbid condition or BMI 40-60
Candidate for Bariatric Surgery

Exclusion Criteria

No pathologies of the GI Tract
No anti-coagulant or non-steroidal anti-inflammatory medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00469391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.