Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

• Sponsor: C. R. Bard (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00394212
• Collaborator: (none)
• Enrollment: 77
• Locations: 10
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Transoral Suturing; Other: Sham Endoscopy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Transoral suturing of the dilated gastrojejunostomy	Device: Transoral Suturing; suturing of anastomosis
Sham Comparator: 2 Sham Endoscopy (suturing not performed)	Other: Sham Endoscopy; suturing not performed

Outcome Measures

Primary Outcome Measures

1. Weight Loss (%) [6 months]

   Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100

Secondary Outcome Measures

1. 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.

2. Subjects Achieving Weight Stabilization at 6 Months [6 months]

   Weight is stabilized if 6 month weight is +/- 2% from baseline weight.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Denver	Colorado	United States
2		Baltimore	Maryland	United States
3		Boston	Massachusetts	United States
4		St. Louis	Missouri	United States
5		Lebanon	New Hampshire	United States
6		New York	New York	United States
7		Cleveland	Ohio	United States
8		Philadelphia	Pennsylvania	United States
9		Dallas	Texas	United States
10		Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• C. R. Bard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT00394212
• Other Study ID Numbers: DVL-EC-002
• First Posted: Oct 31, 2006
• Last Update Posted: Sep 21, 2016
• Last Verified: Oct 1, 2012

• Keywords provided by C. R. Bard: Weight Loss; Transoral Suturing; Dilated gastrojejunostomy; Inadequate weight loss following primary RYGB
• Additional relevant MeSH terms: Weight Loss

Study Results

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 Detail	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.

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)
Period Title: Overall Study
STARTED	50	27
6 Week Follow-up	45	26
3 Month Follow-up	45	26
6 Month Follow-up	43	26
COMPLETED	43	26
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy	Total
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)	Total of all reporting groups
Overall Participants	50	27	77
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 98%	27 100%	76 98.7%
>=65 years	1 2%	0 0%	1 1.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (9.5)	47.6 (7.0)	47.6 (8.6)
Sex: Female, Male (Count of Participants)
Female	47 94%	26 96.3%	73 94.8%
Male	3 6%	1 3.7%	4 5.2%
Region of Enrollment (participants) [Number]
United States	50 100%	27 100%	77 100%

Outcome Measures

1. Primary Outcome

Title	Weight Loss (%)
Description	Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT using Last Observation Carried Forward (LOCF)

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)
Measure Participants	50	27
Mean (Standard Deviation) [percentage of weight lost]	4.2 (5.4)	1.9 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EndoCinch Suturing System:Transoral Suturing, Sham Endoscopy
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments	P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Subjects Achieving 15% Excess Weight Loss (EWL)
Description	%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

Outcome Measure Data

Analysis Population Description

ITT, Last Observation Carried Forward

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)
Measure Participants	50	27
Number [percentage of participants]	41.3 82.6%	25.9 95.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EndoCinch Suturing System:Transoral Suturing, Sham Endoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.317
	Comments	P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Subjects Achieving Weight Stabilization at 6 Months
Description	Weight is stabilized if 6 month weight is +/- 2% from baseline weight.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT, Last Observation Carried Forward

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)
Measure Participants	50	27
Number [percentage of participants]	96.0 192%	77.8 288.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EndoCinch Suturing System:Transoral Suturing, Sham Endoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Subjects Achieving 20% Excess Weight Loss at 6 Months
Description	%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

Outcome Measure Data

Analysis Population Description

ITT, Last Observation Carried Forward

Arm/Group Title	EndoCinch Suturing System:Transoral Suturing	Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy (suturing not performed)
Measure Participants	50	27
Number [percentage of participants]	33.3 66.6%	14.8 54.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EndoCinch Suturing System:Transoral Suturing, Sham Endoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.174
	Comments	P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	EndoCinch Suturing System:Transoral Suturing		Sham Endoscopy
Arm/Group Description	Transoral suturing of the dilated gastrojejunostomy		Sham Endoscopy (suturing not performed)
All Cause Mortality
	EndoCinch Suturing System:Transoral Suturing		Sham Endoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EndoCinch Suturing System:Transoral Suturing		Sham Endoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/48 (4.2%)		0/29 (0%)
Gastrointestinal disorders
Adhesion-related intestinal obstruction (from prior surgery)	1/48 (2.1%)	1	0/29 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary edema secondary to fluid overload	1/48 (2.1%)	1	0/29 (0%)	0
Other (Not Including Serious) Adverse Events
	EndoCinch Suturing System:Transoral Suturing		Sham Endoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/48 (37.5%)		10/29 (34.5%)
Gastrointestinal disorders
Nausea	8/48 (16.7%)	9	3/29 (10.3%)	3
Vomiting	6/48 (12.5%)	6	4/29 (13.8%)	5
Constipation	3/48 (6.3%)	3	4/29 (13.8%)	4
Abdominal Discomfort	4/48 (8.3%)	4	0/29 (0%)	0
Nervous system disorders
Headache	3/48 (6.3%)	4	1/29 (3.4%)	1
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain	5/48 (10.4%)	5	5/29 (17.2%)	5

Limitations/Caveats

Limitations of this study are that study enrollment was prematurely discontinued; therefore the study was underpowered for the analysis of both the primary and secondary effectiveness endpoints.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

First publication of study results will be the multicenter results. In the event no multicenter publication has been made within one to two years of the completion of the study at all centers, Investigators will be free to publish their own single-center results. Investigators seeking publication must submit a draft for sponsor review at least 60 days prior to submission of the draft for publication. Sponsor cannot require changes to the communication and cannot extend the embargo.