LapBand Adjustment to Improve Early Weight Loss

NCT01060592 | Completed Phase 2 Results

• 1 other identifier: 2009-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Gastric Band; LapBand; Bariatric Surgery

Outcome Measures

Primary Outcomes (4)

• %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)

  4-6 weeks post surgery

• %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)

  4-6 weeks post surgery

• % Excess Weight Loss 12 Months After Surgery (Large and Small Bands)

  12m post surgery

• % Excess Weight Loss 12 Months After Surgery (Small Bands Only)

  12m post surgery

Secondary Outcomes (1)

• Number of Band Adjustments Required in the First Year After Surgery

  12 months

Study Arms (2)

Stoma Adjustment at Surgery

EXPERIMENTAL

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.

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

Historic

NO INTERVENTION

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

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.

Stoma Adjustment at Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Actively bleeding varices

Sponsors & Collaborators

• Crospon: lead

Study Sites (1)

Specialty Surgery of Fort Worth

Hurst, Texas, 76054, United States

Location

Related Publications (1)

• Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12.

  RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John O'Dea PhD
• Organization: Crospon

jodea@crospon.com

+353-91-519880

Study Officials

• Robert G Snow, DO FACOS

  AIGB

  PRINCIPAL INVESTIGATOR

• John O'Dea, PhD

  Crospon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2010
• First Posted: February 2, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 8, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-04

Locations

US (1)