Trial Outcomes & Findings for Endoscopic Surgery for Bariatric Revision After Weight Loss Failure (NCT NCT01871896)

NCT ID: NCT01871896

Last Updated: 2023-08-16

Results Overview

We will track patient's weight after their endoscopic bariatric surgery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 3 months after procedure
• Results posted on: 2023-08-16

Participant Flow

24 patients were recruited 23 underwent the proposed procedure

Participant milestones

Measure	All Study Participants Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Overall Study STARTED	24
Overall Study Underwent Procedure	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Study Participants Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

Baseline characteristics by cohort

Measure	Weight Gain n=24 Participants Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Age, Continuous	47.6 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after procedure

We will track patient's weight after their endoscopic bariatric surgery.

Outcome measures

Measure	All Study Participants n=23 Participants Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Mean Weight Loss	13.3 Pounds Interval 0.0 to 40.0

SECONDARY outcome

Timeframe: 2 years

We will track the patient's weight loss and see if their obesity-related co-morbidities resolve.

Outcome measures

Measure	All Study Participants n=23 Participants Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Number of Participants With Resolved Co-morbidities	23 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Data were not collected for this outcome measure. Milestone visit dates at which surveys were going to be provided were not followed through by patients resulting in the lack of data collected.

We will be monitoring patient's tolerance to this procedure and evaluate their satisfaction via a short questionnaire.

Outcome measures

Outcome data not reported

Adverse Events

Weight Gain

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Weight Gain n=24 participants at risk Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Gastrointestinal disorders Leak	4.2% 1/24 • Up to 2 years

Other adverse events

Measure	Weight Gain n=24 participants at risk Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight. Endoscopic Suturing to Create Early Satiety: Evaluating the efficacy of endoscopic suturing for weight loss.
Gastrointestinal disorders Dysphagia	4.2% 1/24 • Number of events 1 • Up to 2 years

Additional Information

Matthew Lin

University of California San Francisco

Phone: 415 353 2161

Email: Matthew.Lin@ucsf.edu

Results disclosure agreements

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