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Completed

NCT Number: NCT00960843

Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety

The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adelaide Bariatric Center, Bedford Park, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to comprehend, follow and give informed consent.
  • Be at least 18 years of age at time of trial enrollment.
  • Had a pre-implantation BMI between 35 and 55 kg/m2.
  • Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment yet)prior to the date of enrollment.
  • Willingness to be randomized to intraband-based or conventional adjustments
  • Willingness to consent to monthly visits and possible measurements of intraband pressure (requiring access to the injection port).
  • Willingness to undergo up to 7 band adjustments within the 6-month period of the study.
  • Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements.
  • Willingness to return to office visits around the same time of the first in-study adjustment (plus or minus 2 hours)
  • Willingness to consent to a limited UGI series if the investigator suspects the presence of a band-related complication or if the intraband pressure recordings deviate from expected.
  • Willingness to refrain from taking medications or supplements indicated for or known to induce weight loss.

Exclusion criteria

  • Females currently known to be pregnant.
  • Ongoing or unresolved band perforation or band leakage.
  • Ongoing (unresolved) slippage, erosion, or pouch dilation.
  • Documented esophageal dysmotility/dyskinesia.
  • Ongoing (unresolved) port obstruction or tube kinking.
  • Current injection port infection.
  • History of band revision or replacement.
  • Previously documented or ongoing esophageal dilatation.
  • Any condition that, in the opinion of the Investigator, may jeopardize the subject's well-being or the soundness of this study.
  • Current use of medications or supplements indicated for or known to induce weight loss at any point during the study.

Treatment and study plan

Intraband pressure recording system

Device

Intraband pressure will be measured by a pressure recording system.

Conventional Adjustment

Other

Band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Primary outcomes

  1. Percent Excess Weight Change at Day 180

    Time frame: Screening to Day 180

    Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.

Secondary outcomes

  1. Mean Static Intraband Pressure at Day 180

    Time frame: Day 180

    Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)

  2. Rate of Weight Loss kg/wk at Day 180

    Time frame: Screening to Day 180

    Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

A Randomized, Controlled, 6-month Study to Compare the Effects of Volume- and Pressure-guided Adjustments on Weight Loss and Satiety in Patients Implanted With the Swedish Adjustable Gastric Band

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2009
Registry last updated
Aug 20, 2012

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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