Morbid ObesityNCT01078194
Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
An observational study of Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass
Who may be able to join
- Weight regain of more than 10 kg from nadir
- Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass
Who cannot join
- Formerly leak at the gastrojejunostomy
- Formerly open abdominal surgery
- Anastomotic ulcer
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Surgery
Vienna, 1090
Gerhard Prager, M-D-, +43-1-40400 ext. 5621, gerhard.prager@meduniwien.ac.at
Felix B Langer, M.D., +43-1-40400 ext. 5621, felix.langer@meduniwien.ac.at
About this study
Official title: Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.
- Conditions
- Morbid Obesity
- Being tested
- Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)
- Keywords
- Weight regain, Weight loss failure, Gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)Device
Also called A.M.I. Soft Gastric Band
Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding
| Study group | Role | What they receive |
|---|---|---|
| Weight regain / weight loss failure | Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass Receives: Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Excessive weight loss
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Prager, M.D., Principal investigator, Medical University of Vienna, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078194
- Sponsor's protocol ID
- MUW ADIP STUDY 16
- Status last verified
- Jan 2010
- First submitted
- 1 Mar 2010
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
- ClinicalTrials.gov ID
- NCT01078194
- Acronym / sponsor ID
- MUW ADIP STUDY 16
- Conditions
- Morbid Obesity
- Keywords
- Weight regain, Weight loss failure, Gastric bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight regain / weight loss failure | – | Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass
Key inclusion criteria (2 listed)
- Weight regain of more than 10 kg from nadir
- Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass
Key exclusion criteria (3 listed)
- Formerly leak at the gastrojejunostomy
- Formerly open abdominal surgery
- Anastomotic ulcer
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 |
|---|---|---|
| Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)Also: A.M.I. Soft Gastric BandSecondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding | Device | Weight regain / weight loss failure |
Primary outcome
Weight loss
Time frame: 2 years
Excessive weight loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
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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.
Gerhard Prager, M.D. principal investigator
Medical University of Vienna, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Prager, M.D. (+43-1-40400 ext. 5621, gerhard.prager@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 2 years). 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 25 May 2010.