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Endoscopic Suturing for Primary Obesity Treatment (PROMISE)

Primary Purpose

Obesity, Body Weight, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic gastric restrictive procedure
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, BMI, Weight loss, Gastric restriction, Bariatrics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has met diabetic lab testing and all pre-procedural qualifications
  • Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
  • Subject has a BMI of > 30 and < 35
  • Subject has history of obesity for > 2 yrs
  • Subject has had no significant weight change (<5% of total body weight)in last 6 months
  • Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline
  • Subject is a reasonable candidate for general anesthesia
  • Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial
  • Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
  • Subject must be able to fully understand and be willing to sign the informed consent

Exclusion Criteria:

  • Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
  • Mallampati (intubation) score greater than 3
  • Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
  • Subject has history or present use of insulin or insulin derivatives for treatment of diabetes
  • Subject has diabetes secondary to a specific disease
  • Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years
  • Subject has history of inflammatory disease of GI tract
  • Subject has a history of intestinal strictures or adhesions
  • Subject has renal and/or hepatic insufficiency
  • Subject has chronic pancreatic disease
  • Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer
  • Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility
  • Subject has a history of any significant abdominal surgery
  • Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis
  • Subject has a hiatal hernia > 2cm
  • Subject has chronic/acute upper GI bleeding conditions
  • Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation
  • Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating
  • Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  • Subject has cancer or life expectancy of < 2 yrs
  • Subject has systemic infection in the body at the time of the plication procedure.
  • Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period.
  • Subjects who have started medications within the last 3 months that are known to cause weight gain
  • Subjects undergoing chronic steroid therapy
  • Subjects undergoing immunosuppressive therapy
  • Subject has a history of drug or alcohol abuse
  • Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders
  • Subject is non-ambulatory or has significant impairment of mobility
  • Subject has known hormonal or genetic cause for obesity
  • Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator.
  • Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study

Sites / Locations

  • Jackson Health System
  • Brigham and Women's Hospital
  • St. Joseph's Regional Medical Center at New Jersey
  • University of Texas at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic gastric restrictive procedure

Arm Description

Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
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
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.

Secondary Outcome Measures

Percent Excess Weight Loss
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
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.
Percentage of Total Body Weight Loss
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)
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)
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)

Full Information

First Posted
June 15, 2012
Last Updated
February 12, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Apollo Endosurgery, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01662024
Brief Title
Endoscopic Suturing for Primary Obesity Treatment
Acronym
PROMISE
Official Title
Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Apollo Endosurgery, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. 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.
Detailed Description
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. Secondary Endpoints: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Body Weight, Overweight
Keywords
Obesity, BMI, Weight loss, Gastric restriction, Bariatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic gastric restrictive procedure
Arm Type
Experimental
Arm Description
Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
Intervention Type
Device
Intervention Name(s)
Endoscopic gastric restrictive procedure
Other Intervention Name(s)
Apollo Overstitch Endoscopic Suturing System
Intervention Description
Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
12 months
Title
Evaluation of Technical Feasibility of the Procedure
Description
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.
Time Frame
Day 0 - Procedure Day
Secondary Outcome Measure Information:
Title
Percent Excess Weight Loss
Description
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
Time Frame
12 Months
Title
Durability
Description
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.
Time Frame
12 months
Title
Percentage of Total Body Weight Loss
Description
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss
Time Frame
12 Months
Title
BMI Loss (kg/m^2)
Description
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)
Time Frame
12 Months
Title
Waist Circumference Loss (cm)
Description
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has met diabetic lab testing and all pre-procedural qualifications Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age Subject has a BMI of > 30 and < 35 Subject has history of obesity for > 2 yrs Subject has had no significant weight change (<5% of total body weight)in last 6 months Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline Subject is a reasonable candidate for general anesthesia Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits. Subject must be able to fully understand and be willing to sign the informed consent Exclusion Criteria: Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure Mallampati (intubation) score greater than 3 Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed Subject has history or present use of insulin or insulin derivatives for treatment of diabetes Subject has diabetes secondary to a specific disease Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years Subject has history of inflammatory disease of GI tract Subject has a history of intestinal strictures or adhesions Subject has renal and/or hepatic insufficiency Subject has chronic pancreatic disease Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility Subject has a history of any significant abdominal surgery Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis Subject has a hiatal hernia > 2cm Subject has chronic/acute upper GI bleeding conditions Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. Subject has cancer or life expectancy of < 2 yrs Subject has systemic infection in the body at the time of the plication procedure. Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period. Subjects who have started medications within the last 3 months that are known to cause weight gain Subjects undergoing chronic steroid therapy Subjects undergoing immunosuppressive therapy Subject has a history of drug or alcohol abuse Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders Subject is non-ambulatory or has significant impairment of mobility Subject has known hormonal or genetic cause for obesity Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher C. Thompson, MD, MS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Joseph's Regional Medical Center at New Jersey
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University of Texas at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.
Citations:
PubMed Identifier
16595758
Citation
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
Results Reference
background
PubMed Identifier
10432328
Citation
Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
Results Reference
background
PubMed Identifier
12814714
Citation
Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.
Results Reference
background
PubMed Identifier
15616203
Citation
Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
Results Reference
background
PubMed Identifier
15454136
Citation
Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.
Results Reference
background
PubMed Identifier
11967669
Citation
Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.
Results Reference
background
PubMed Identifier
22658388
Citation
Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.
Results Reference
background

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Endoscopic Suturing for Primary Obesity Treatment

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