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

Ethicon

Status

Completed

Conditions

Morbid Obesity

Treatments

Other: Conventional Adjustment

Device: Intraband pressure recording system

Study type

Interventional

Funder types

Industry

Identifiers

NCT00960843

CI-08-0009

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.