ObesityPhase 3NCT00394212
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
A Phase 3 study testing Transoral Suturing in people with Obesity, run by C. R. Bard at 10 sites in United States.
Trial summary
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Transoral Suturing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2006to May 2009
- Phase
- Phase 3
- 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
- 6 months post primary RYGB with inadequate weight loss or weight regain
- BMI >30 and ≤ 50
- Dilated gastrojejunal anastomosis
- Successfully completes screening process
- Signed consent
Who cannot join
- Recently quit smoking or plan to quit within the next year
- Pregnant or planning to become pregnant over the course of the next 9 months
- Mallampati score of 4
- Serious systemic disease or active disease of the gastrointestinal tract
- Gastric pouch abnormalities
- Significant movement limitations
Show all 16Show fewer
- Use of weight-promoting or weight-reduction drugs during study period
- Severe eating disorders
- Uncontrolled depression or psychoses
- Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
- History of significant cardiovascular, cerebrovascular or pulmonary disease
- Not a candidate for conscious or general sedation
- Anticoagulant therapies
- Active substance abuse
- Life expectancy < 1 year
- Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Lebanon, New Hampshire
Study site
Milwaukee, Wisconsin
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
St Louis, Missouri
About this study
Official title: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.
For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.
The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.
- Conditions
- Obesity
- Being tested
- Transoral Suturing, Sham Endoscopy
- Keywords
- Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral SuturingDevice
suturing of anastomosis
Sham EndoscopyOther
suturing not performed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transoral suturing of the dilated gastrojejunostomy Receives: Device: Transoral Suturing |
| 2 | Sham comparator | Sham Endoscopy (suturing not performed) Receives: Other: Sham Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss (%)
Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100
Measured: 6 months
Secondary outcomes (3)
Subjects Achieving 15% Excess Weight Loss (EWL)
%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.
Measured: 6 months
Subjects Achieving Weight Stabilization at 6 Months
Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Measured: 6 months
Subjects Achieving 20% Excess Weight Loss at 6 Months
%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionMay 2009
Why it stopped: For business reasons
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394212
- Sponsor's protocol ID
- DVL-EC-002
- Status last verified
- Oct 2012
- First submitted
- 27 Oct 2006
- Last updated
- 21 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.
PubMed 23567348
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT00394212
- Acronym / sponsor ID
- DVL-EC-002
- Conditions
- Obesity
- Keywords
- Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business reasons
- Enrolment
- 77 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Oct 2006 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.
For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.
The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Transoral SuturingTransoral suturing of the dilated gastrojejunostomy |
| 2 | Sham comparator | Other: Sham EndoscopySham Endoscopy (suturing not performed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 6 months post primary RYGB with inadequate weight loss or weight regain
- BMI >30 and ≤ 50
- Dilated gastrojejunal anastomosis
- Successfully completes screening process
- Signed consent
Key exclusion criteria (16 listed)
- Recently quit smoking or plan to quit within the next year
- Pregnant or planning to become pregnant over the course of the next 9 months
- Mallampati score of 4
- Serious systemic disease or active disease of the gastrointestinal tract
- Gastric pouch abnormalities
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 |
|---|---|---|
| Transoral Suturingsuturing of anastomosis | Device | 1 |
| Sham Endoscopysuturing not performed | Other | 2 |
Primary outcome
Weight Loss (%)
Time frame: 6 months
Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100
3 secondary outcomes
Subjects Achieving 15% Excess Weight Loss (EWL)
Time frame: 6 months
Subjects Achieving Weight Stabilization at 6 Months
Time frame: 6 months
Subjects Achieving 20% Excess Weight Loss at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23567348Thompson CC, Chand B, Chen YK, DeMarco DC, Miller L, Schweitzer M, Rothstein RI, Lautz DB, Slattery J, Ryan MB, Brethauer S, Schauer P, Mitchell MC, Starpoli A, Haber GB, Catalano MF, Edmundowicz S, Fagnant AM, Kaplan LM, Roslin MS. Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery. Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transoral Suturing in people with Obesity, run by C. R. Bard at 10 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 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?
Weight Loss (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394212, which also lists 1 linked publication.
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 21 Sep 2016.