Status:
COMPLETED
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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 metho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00960843
Start Date
July 1 2009
End Date
November 1 2010
Last Update
August 20 2012
Active Locations (2)
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1
Adelaide Bariatric Center
Bedford Park, South Australia, Australia, 5042
2
OB Klinika, a.s.
Prague, Czechia