Phase 2 Completed N=56 Randomized Single-blind Treatment

Multi-Center Pre-Bariatric Weight Loss Study

Obesity

Source: ClinicalTrials.gov NCT00469391 ↗

Enrolled (actual)

Serious AEs

4.3%

Results posted

Dec 2016

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

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.

Outcome Measures

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

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. Informational only — not medical advice.