LapBand Adjustment to Improve Early Weight Loss

Crospon

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity

Treatments: Device: EndoFLIP device (FDA Device Listing Number : D091203)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060592

2009-02

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing gastric band surgery
• Over 18 years of age

Exclusion criteria

• Actively bleeding varices

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Stoma Adjustment at Surgery

Experimental group

Description:

The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment.

Treatment:

Device: EndoFLIP device (FDA Device Listing Number : D091203)

Historic

No Intervention group

Description:

Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone