At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
Intraband pressure recording system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Intraband pressure recording system and Conventional Adjustment for Morbid Obesity. Completed, enrolled 51 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity
CountriesAustralia, Czechia
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedAug 18, 2009
Enrollment StartJul 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.9 years ago
Interventions
Intraband pressure recording systemdevice
Intraband pressure will be measured by a pressure recording system.
Conventional Adjustmentother
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).