Trial Outcomes & Findings for Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass (NCT NCT00394212)

NCT ID: NCT00394212

Last Updated: 2016-09-21

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 77 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-09-21

Participant Flow

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.

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.

Participant milestones

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

Reasons for withdrawal

Measure	EndoCinch Suturing System:Transoral Suturing Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy Sham Endoscopy (suturing not performed)
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	EndoCinch Suturing System:Transoral Suturing n=50 Participants Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=27 Participants Sham Endoscopy (suturing not performed)	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	27 Participants n=7 Participants	76 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	47.6 years STANDARD_DEVIATION 9.5 • n=5 Participants	47.6 years STANDARD_DEVIATION 7.0 • n=7 Participants	47.6 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	26 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	27 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT using Last Observation Carried Forward (LOCF)

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

Outcome measures

Measure	EndoCinch Suturing System:Transoral Suturing n=50 Participants Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=27 Participants Sham Endoscopy (suturing not performed)
Weight Loss (%)	4.2 percentage of weight lost Standard Deviation 5.4	1.9 percentage of weight lost Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 months

Population: ITT, Last Observation Carried Forward

%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.

Outcome measures

Measure	EndoCinch Suturing System:Transoral Suturing n=50 Participants Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=27 Participants Sham Endoscopy (suturing not performed)
Subjects Achieving 15% Excess Weight Loss (EWL)	41.3 percentage of participants	25.9 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT, Last Observation Carried Forward

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

Outcome measures

Measure	EndoCinch Suturing System:Transoral Suturing n=50 Participants Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=27 Participants Sham Endoscopy (suturing not performed)
Subjects Achieving Weight Stabilization at 6 Months	96.0 percentage of participants	77.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: ITT, Last Observation Carried Forward

%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100

Outcome measures

Measure	EndoCinch Suturing System:Transoral Suturing n=50 Participants Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=27 Participants Sham Endoscopy (suturing not performed)
Subjects Achieving 20% Excess Weight Loss at 6 Months	33.3 percentage of participants	14.8 percentage of participants

Adverse Events

EndoCinch Suturing System:Transoral Suturing

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Sham Endoscopy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	EndoCinch Suturing System:Transoral Suturing n=48 participants at risk Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=29 participants at risk Sham Endoscopy (suturing not performed)
Gastrointestinal disorders Adhesion-related intestinal obstruction (from prior surgery)	2.1% 1/48 • Number of events 1 • 6 months	0.00% 0/29 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary edema secondary to fluid overload	2.1% 1/48 • Number of events 1 • 6 months	0.00% 0/29 • 6 months

Other adverse events

Measure	EndoCinch Suturing System:Transoral Suturing n=48 participants at risk Transoral suturing of the dilated gastrojejunostomy	Sham Endoscopy n=29 participants at risk Sham Endoscopy (suturing not performed)
Gastrointestinal disorders Nausea	16.7% 8/48 • Number of events 9 • 6 months	10.3% 3/29 • Number of events 3 • 6 months
Gastrointestinal disorders Vomiting	12.5% 6/48 • Number of events 6 • 6 months	13.8% 4/29 • Number of events 5 • 6 months
Gastrointestinal disorders Constipation	6.2% 3/48 • Number of events 3 • 6 months	13.8% 4/29 • Number of events 4 • 6 months
Gastrointestinal disorders Abdominal Discomfort	8.3% 4/48 • Number of events 4 • 6 months	0.00% 0/29 • 6 months
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	10.4% 5/48 • Number of events 5 • 6 months	17.2% 5/29 • Number of events 5 • 6 months
Nervous system disorders Headache	6.2% 3/48 • Number of events 4 • 6 months	3.4% 1/29 • Number of events 1 • 6 months

Additional Information

Dawn Heimer, Clinical Research

Davol Inc., Subsidiary of C.R. Bard

Phone: 401-825-8681

Email: Dawn.Heimer@crbard.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER