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OpenTrials
Completed

NCT Number: NCT01060592

LapBand Adjustment to Improve Early Weight Loss

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Specialty Surgery of Fort Worth

Hurst, Texas, 76054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Actively bleeding varices

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 4-6 weeks post surgery

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

    Time frame: 4-6 weeks post surgery

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

    Time frame: 12m post surgery

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

    Time frame: 12m post surgery

Secondary outcomes

  1. Number of Band Adjustments Required in the First Year After Surgery

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Crospon

Industry

Registry information

Official study title

Effect on Early Weight Loss by Adjusting Gastric Band During Surgery

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 2, 2010
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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