Phase 3
N=84
LapBand Adjustment to Improve Early Weight Loss
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01060592 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) — 15.63; 20.8 %EWL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EndoFLIP device (FDA Device Listing Number : D091203) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Crospon
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) |
15.63; 20.8 | — |
| PRIMARY %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) |
16.33; 23.07 | — |
| PRIMARY % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) |
48.3; 50.4 | — |
| PRIMARY % Excess Weight Loss 12 Months After Surgery (Small Bands Only) |
48.71; 60.32 | — |
| SECONDARY Number of Band Adjustments Required in the First Year After Surgery |
6.47; 6.66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing gastric band surgery
- Over 18 years of age
Exclusion Criteria
- Actively bleeding varices
Data sourced from ClinicalTrials.gov (NCT01060592). 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.