Clinical trial NCT00960843: Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Gastric Banding
Bariatric Banding
Swedish Adjustable Gastric Band
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Excess Weight Change at Day 180
timeFrame: Screening to Day 180
Secondary outcomes:
measure: Mean Static Intraband Pressure at Day 180
timeFrame: Day 180
measure: Rate of Weight Loss kg/wk at Day 180
timeFrame: Screening to Day 180
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Adelaide Bariatric Center
state: South Australia
city: Prague
country: Czech Republic
facility: OB Klinika, a.s.
Study officials:
References: