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LapBand Adjustment to Improve Early Weight Loss

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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