None listed
Conditions
Brief summary
This study is being conducted in order to learn more about a potential new way to monitor the adjustments of the Swedish Adjustable Gastric Band. Currently doctors generally monitor band adjustments based on the volume of fluid that is used to inflate the band. This study will evaluate whether it is possible to consistently measure the pressure within the gastric band. The information obtained will be used to establish if it is feasible to use pressure based adjustments in the future
Interventions
Gastric Band adjustments are performed to vary the degree of restriction the band delivers hence allowing more or less food consumption. The adjustment is made by injection of saline into the band. The frequency of routine band adjustment is dependent on degree of weight loss.
The subject will be asked to swallow a measured amount of water, the band will be adjusted per standard hospital procedure, then another measured amount of water and one of three food or juice substances will be consumed
Gastric Band adjustments are performed to vary the degree of restriction the band delivers hence allowing more or less food consumption. The adjustment is made by injection of saline into the band. The frequency of routine band adjustment is dependent on degree of weight loss. The subject will be asked to swallow a measured amount of water, the band will be adjusted per standard hospital procedure, then another measured amount of water and one of three food or juice substances will be consumed. A pressure transducer (sensor) which is connected to the standard adjustment equipment (outside the body) will detect the pressure within the gastric band as the food is swallowed. The pressure will be recorded on a computer. The procedure may take up to 30 minutes. The measurements will be taken during one adjustment only. The study consists of three parts, Phase one Part one assesses which substance provides the most consistent pressure pattern, Phase 1 Part 2 tests what volume provides the most consistent pressure reading. Phase 2 tests the differences and consistency in pressures within the band. Assignment to each phase is sequential and is dependent on the preceeding number of patients enrolled.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Provide informed consent. Documented date of Gastric Band insertionUndergoing 1st, 2nd or 3rd band adjustment
Exclusion criteria
Females known to be pregnantKnown food allergies to the test mediaHistory of port obstructionCurrent port infectionHistory of revision of band systemHistory of oesophageal dysmotility or dilationConsumption of solid food within 4 hours of study band adjustmentConsumption of liquids within 2 hours of study band adjustmentAny condition that in the opinion of the investigator may jeopardize the subject's well-being and/or the soundness of the study.
Outcome results
None listed