CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 35 enrolled
Drug / intervention
EndoFLIP device (FDA Device Listing Number : D091203)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01060592
NCT01060592Phase 3Completed
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Effect on Early Weight Loss by Adjusting Gastric Band During Surgery

Crospon·interventional·Posted Feb 2, 2010·Updated Apr 8, 2013

In Brief

A Phase 3 clinical trial evaluating EndoFLIP device (FDA Device Listing Number : D091203) for Obesity. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2010
Enrollment StartOct 1, 2009
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.4 years ago

Interventions

EndoFLIP device (FDA Device Listing Number : D091203)device

The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.