Endoscopic Suturing for Primary Obesity Treatment (PROMISE)
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|ClinicalTrials.gov Identifier: NCT01662024|
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Body Weight Overweight||Device: Endoscopic gastric restrictive procedure||Not Applicable|
The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.
The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure.
Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months.
Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline:
- Percent excess weight loss (%EWL)
- Total weight lost (kg) and percent weight lost
- Change in (BMI) and percent change in BMI
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
- Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline)
- Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline)
- Durability: 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||April 2016|
Experimental: Endoscopic gastric restrictive procedure
Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Device: Endoscopic gastric restrictive procedure
Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Other Name: Apollo Overstitch Endoscopic Suturing System
- Number of Participants With Adverse Events [ Time Frame: 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.
- Evaluation of Technical Feasibility of the Procedure [ Time Frame: 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.
- Percent Excess Weight Loss [ Time Frame: 12 Months ]Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
- Durability [ Time Frame: 12 months ]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.
- Percentage of Total Body Weight Loss [ Time Frame: 12 Months ]Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss
- BMI Loss (kg/m^2) [ Time Frame: 12 Months ]Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)
- Waist Circumference Loss (cm) [ Time Frame: 12 Months ]Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662024
|United States, Florida|
|Jackson Health System|
|Miami, Florida, United States, 33176|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New Jersey|
|St. Joseph's Regional Medical Center at New Jersey|
|Paterson, New Jersey, United States, 07503|
|United States, Texas|
|University of Texas at Houston|
|Bellaire, Texas, United States, 77401|
|Principal Investigator:||Christopher C. Thompson, MD, MS||Brigham and Women's Hospital|