Morbid ObesityNCT00960843
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
A study testing Intraband pressure recording system and Conventional Adjustment in people with Morbid Obesity, run by Ethicon Endo-Surgery at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Intraband pressure recording system and Conventional Adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Adelaide Bariatric Center
Bedford Park, South Australia, 5042
About this study
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
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.
- Conditions
- Morbid Obesity
- Being tested
- Intraband pressure recording system, Conventional Adjustment
- Keywords
- Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Adjustment Group | Active comparator | Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). Receives: Other: Conventional Adjustment |
| Intraband Pressure Arm | Active comparator | Subjects whose band adjustments will be guided by intraband pressure readings. Receives: Device: Intraband pressure recording system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Excess Weight Change at Day 180
Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.
Measured: Screening to Day 180
Secondary outcomes (2)
Mean Static Intraband Pressure at Day 180
Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)
Measured: Day 180
Rate of Weight Loss kg/wk at Day 180
Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).
Measured: Screening to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960843
- Sponsor's protocol ID
- CI-08-0009
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2009
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00960843
- Acronym / sponsor ID
- CI-08-0009
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Posted 3 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Adjustment Group | Active comparator | Other: Conventional AdjustmentSubject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
| Intraband Pressure Arm | Active comparator | Device: Intraband pressure recording systemSubjects whose band adjustments will be guided by intraband pressure readings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraband pressure recording systemIntraband pressure will be measured by a pressure recording system. | Device | Intraband Pressure Arm |
| Conventional AdjustmentBand adjustments will be made via conventional standard of care (e.g., volume, hunger). | Other | Conventional Adjustment Group |
Primary outcome
Percent Excess Weight Change at Day 180
Time frame: Screening to Day 180
Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.
2 secondary outcomes
Mean Static Intraband Pressure at Day 180
Time frame: Day 180
Rate of Weight Loss kg/wk at Day 180
Time frame: Screening to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraband pressure recording system and Conventional Adjustment in people with Morbid Obesity, run by Ethicon Endo-Surgery at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Excess Weight Change at Day 180 (time frame: Screening to Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.