Obesity
Conditions
Keywords
Weight Loss, Transoral Suturing, Dilated gastrojejunostomy, Inadequate weight loss following primary RYGB
Brief 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. 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.
Interventions
DEVICETransoral Suturing
suturing of anastomosis
OTHERSham Endoscopy
suturing not performed
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss (%) | 6 months | Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Achieving 15% Excess Weight Loss (EWL) | 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. |
| Subjects Achieving Weight Stabilization at 6 Months | 6 months | Weight is stabilized if 6 month weight is +/- 2% from baseline weight. |
| Subjects Achieving 20% Excess Weight Loss at 6 Months | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at bariatric centers of excellence with screening initiated on 25Oct2006. The first randomized procedure was performed on 3Apr2007. The last subject follow-up was performed 8May2009.
Pre-assignment details
Prior to enrollment, prospective candidates having provided informed consent were screened for eligibility during a formal 6 week screening period. Screening performed by a multidisciplinary team including surgeon and/or endoscopist, psychiatric professional and registered dietician.
Participants by arm
| Arm | Count |
|---|---|
| EndoCinch Suturing System:Transoral Suturing Transoral suturing of the dilated gastrojejunostomy | 50 |
| Sham Endoscopy Sham Endoscopy (suturing not performed) | 27 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | EndoCinch Suturing System:Transoral Suturing | Sham Endoscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 27 Participants | 76 Participants |
| Age, Continuous | 47.6 years STANDARD_DEVIATION 9.5 | 47.6 years STANDARD_DEVIATION 7 | 47.6 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 50 participants | 27 participants | 77 participants |
| Sex: Female, Male Female | 47 Participants | 26 Participants | 73 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 48 | 10 / 29 |
| serious Total, serious adverse events | 2 / 48 | 0 / 29 |
Outcome results
Primary
Weight Loss (%)
Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100
Time frame: 6 months
Population: ITT using Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoCinch Suturing System:Transoral Suturing | Weight Loss (%) | 4.2 percentage of weight lost | Standard Deviation 5.4 |
| Sham Endoscopy | Weight Loss (%) | 1.9 percentage of weight lost | Standard Deviation 5.2 |
Comparison: Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.p-value: 0.066Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 6 months
Population: ITT, Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoCinch Suturing System:Transoral Suturing | Subjects Achieving 15% Excess Weight Loss (EWL) | 41.3 percentage of participants |
| Sham Endoscopy | Subjects Achieving 15% Excess Weight Loss (EWL) | 25.9 percentage of participants |
p-value: 0.317Fisher Exact
Secondary
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
Time frame: 6 months
Population: ITT, Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoCinch Suturing System:Transoral Suturing | Subjects Achieving 20% Excess Weight Loss at 6 Months | 33.3 percentage of participants |
| Sham Endoscopy | Subjects Achieving 20% Excess Weight Loss at 6 Months | 14.8 percentage of participants |
p-value: 0.174Fisher Exact
Secondary
Subjects Achieving Weight Stabilization at 6 Months
Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Time frame: 6 months
Population: ITT, Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoCinch Suturing System:Transoral Suturing | Subjects Achieving Weight Stabilization at 6 Months | 96.0 percentage of participants |
| Sham Endoscopy | Subjects Achieving Weight Stabilization at 6 Months | 77.8 percentage of participants |
p-value: 0.019Fisher Exact