ObesityNCT00411489
Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
A study testing endolumenal surgery in people with Obesity, run by USGI Medical at 4 sites in United States.
Trial summary
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- endolumenal surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 yrs of age or older and < 65 yrs of age
- At least 2 yrs post-Roux-En-Y gastric bypass surgery
- Initially achieved at least 50% weight loss
- At enrollment, has regain at least 15% of weight loss
- BMI 40 or greater or 35 or greater with one or more co-morbidities
- Stoma diameter at least 20 mm
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- Completes successful nutritional screening
- Is a candidate for a surgical revision procedure
- Is a reasonable risk to undergo general anesthesia
- Completes successful cardiopulmonary evaluation
- ASA Classification of less than or equal to III
- Able to provide written consent
- Able to return for protocol-specified evaluations
Who cannot join
- Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
- Previous bariatric revision procedure
- Has another causal factor for weight regain other than stoma or pouch dilatation
- Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Mt. Sinai School of Medicine
New York, New York, 10029-6574
Columbia-Presbyterian Medical Center
New York, New York, 10032
Oregon Clinic
Portland, Oregon, 97210
About this study
Official title: Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.
- Conditions
- Obesity
- Being tested
- endolumenal surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endolumenal surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee L Swanstrom, MD, Principal investigator, Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411489
- Sponsor's protocol ID
- TP0165
- Other IDs
- TP0165
- Status last verified
- Jun 2007
- First submitted
- 12 Dec 2006
- Last updated
- 18 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
- ClinicalTrials.gov ID
- NCT00411489
- Acronym / sponsor ID
- TP0165
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- First posted
- 14 Dec 2006 (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.
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure. This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 yrs of age or older and < 65 yrs of age
- At least 2 yrs post-Roux-En-Y gastric bypass surgery
- Initially achieved at least 50% weight loss
- At enrollment, has regain at least 15% of weight loss
- BMI 40 or greater or 35 or greater with one or more co-morbidities
Key exclusion criteria (4 listed)
- Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
- Previous bariatric revision procedure
- Has another causal factor for weight regain other than stoma or pouch dilatation
- Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program
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 |
|---|---|---|
| endolumenal surgery | Procedure or surgery | – |
Primary outcome
weight loss
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2008.
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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.
Lee L Swanstrom, MD principal investigator
Oregon Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endolumenal surgery in people with Obesity, run by USGI Medical at 4 sites in United States.
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 13 inclusion and 4 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 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weight loss. 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 18 Mar 2008.