Endoscopic Suturing for Primary Obesity Treatment (PROMISE)

Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Body Weight
• Intervention / Treatment: Device: Endoscopic gastric restrictive procedure

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:

1. 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)
2. 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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Jackson Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New Jersey
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Regional Medical Center at New Jersey
  • Texas
    • Bellaire, Texas, United States, 77401
      • University of Texas at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Apollo Overstitch Endoscopic Suturing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	Day 0 - Procedure Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Excess Weight Loss	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss	12 Months
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.	12 months
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	12 Months
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)	12 Months
Waist Circumference Loss (cm)	Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)	12 Months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Apollo Endosurgery, Inc.
• Investigators: Principal Investigator: Christopher C. Thompson, MD, MS, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: February 12, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; BMI; Bariatrics; Gastric restriction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Overweight; Body Weight
• Other Study ID Numbers: 2012P-000799

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• 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