Trial Outcomes & Findings for Endoscopic Suturing for Primary Obesity Treatment (NCT NCT01662024)

NCT ID: NCT01662024

Last Updated: 2017-03-30

Results Overview

Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-03-30

Participant Flow

Participant milestones

Measure	Endoscopic Gastric Restrictive Procedure Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Endoscopic Gastric Restrictive Procedure Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Overall Study Pregnancy	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Endoscopic Suturing for Primary Obesity Treatment

Baseline characteristics by cohort

Measure	Endoscopic Gastric Restrictive Procedure n=20 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Age, Continuous	36.7 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Initial Weight (kg)	90.4 kg n=5 Participants
Initial BMI (kg/m^2)	33.4 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.

Outcome measures

Measure	Endoscopic Gastric Restrictive Procedure n=20 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Number of Participants With Adverse Events Peri-operative Adverse Events	5 Participants
Number of Participants With Adverse Events Post-operative Adverse Events	2 Participants
Number of Participants With Adverse Events Delayed Adverse Events	0 Participants
Number of Participants With Adverse Events No Adverse Events	13 Participants

PRIMARY outcome

Timeframe: Day 0 - Procedure Day

Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.

Outcome measures

Measure	Endoscopic Gastric Restrictive Procedure n=20 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.
Evaluation of Technical Feasibility of the Procedure Running Sutures	10.4 Sutures Interval 9.9 to 10.9
Evaluation of Technical Feasibility of the Procedure Total Stitches	54.4 Sutures Interval 51.9 to 56.9
Evaluation of Technical Feasibility of the Procedure Interrupted Sutures	4 Sutures Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: 12 Months

Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss

Outcome measures

Measure

Endoscopic Gastric Restrictive Procedure n=15 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.

Percent Excess Weight Loss

70.8 Percentage of excess weight lost Interval 62.8 to 78.8

SECONDARY outcome

Timeframe: 12 months

Population: Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.

Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.

Outcome measures

Measure

Endoscopic Gastric Restrictive Procedure Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.

Durability

0

SECONDARY outcome

Timeframe: 12 Months

Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss

Outcome measures

Measure

Endoscopic Gastric Restrictive Procedure n=15 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.

Percentage of Total Body Weight Loss

18.1 Percentage of total weight lost Interval 15.8 to 20.4

SECONDARY outcome

Timeframe: 12 Months

Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)

Outcome measures

Measure

Endoscopic Gastric Restrictive Procedure n=15 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.

BMI Loss (kg/m^2)

6.1 kg/m^2 Interval 5.3 to 6.9

SECONDARY outcome

Timeframe: 12 Months

Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)

Outcome measures

Measure

Endoscopic Gastric Restrictive Procedure n=15 Participants Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.

Waist Circumference Loss (cm)

16 cm Interval 13.6 to 18.4

Adverse Events

Endoscopic Gastric Restrictive Procedure

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Endoscopic Gastric Restrictive Procedure n=20 participants at risk Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach. Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.
Gastrointestinal disorders Perioperative Abdominal Pain	10.0% 2/20 • 12 month period of adverse event data collection.
Gastrointestinal disorders Perioperative Nausea/Vomiting	15.0% 3/20 • 12 month period of adverse event data collection.
Gastrointestinal disorders Post-operative Abdominal Pain	5.0% 1/20 • 12 month period of adverse event data collection.
Gastrointestinal disorders Post-operative Nausea	5.0% 1/20 • 12 month period of adverse event data collection.

Additional Information

Christopher C. Thompson, MD, MSc

Brigham and Women's Hospital

Phone: 617-525-8266

Email: ccthompson@bwh.harvard.edu

Results disclosure agreements

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