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

Morbid Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960843
• Other study ID #: CI-08-0009
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: August 14, 2012
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• Intraband pressure recording system
Intraband pressure will be measured by a pressure recording system.

Other:
• Conventional Adjustment
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Locations

Country	Name	City	State
Australia	Adelaide Bariatric Center	Bedford Park	South Australia
Czech Republic	OB Klinika, a.s.	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

Australia,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No