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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Intraband pressure recording system
* Other: Conventional Adjustment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Adjustment Group<br>Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). | Other: Conventional Adjustment<br>* Band adjustments will be made via conventional standard of care (e.g., volume, hunger).<br>|
| Active Comparator: Intraband Pressure Arm<br>Subjects whose band adjustments will be guided by intraband pressure readings. | Device: Intraband pressure recording system<br>* Intraband pressure will be measured by a pressure recording system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Excess Weight Change at 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. | Screening to Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Static Intraband Pressure at 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) | Day 180 | 
| Rate of Weight Loss kg/wk at 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). | Screening to Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band