Body Weight, Obesity, Overweight
Conditions
Keywords
Obesity, BMI, Weight loss, Gastric restriction, Bariatrics
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: 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.
Interventions
DEVICEEndoscopic gastric restrictive procedure
Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
Sponsors
Apollo Endosurgery, Inc.
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Total Body Weight Loss | 12 Months | Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss |
| Percent Excess Weight Loss | 12 Months | Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss |
| Waist Circumference Loss (cm) | 12 Months | Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm) |
| BMI Loss (kg/m^2) | 12 Months | Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m\^2) |
| Durability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pregnancy | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Endoscopic Gastric Restrictive Procedure |
|---|---|
| Age, Continuous | 36.7 years |
| Initial BMI (kg/m^2) | 33.4 kg/m^2 |
| Initial Weight (kg) | 90.4 kg |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Day 0 - Procedure Day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Evaluation of Technical Feasibility of the Procedure | Running Sutures | 10.4 Sutures |
| Endoscopic Gastric Restrictive Procedure | Evaluation of Technical Feasibility of the Procedure | Total Stitches | 54.4 Sutures |
| Endoscopic Gastric Restrictive Procedure | Evaluation of Technical Feasibility of the Procedure | Interrupted Sutures | 4 Sutures |
Primary
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.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Number of Participants With Adverse Events | Peri-operative Adverse Events | 5 Participants |
| Endoscopic Gastric Restrictive Procedure | Number of Participants With Adverse Events | Post-operative Adverse Events | 2 Participants |
| Endoscopic Gastric Restrictive Procedure | Number of Participants With Adverse Events | Delayed Adverse Events | 0 Participants |
| Endoscopic Gastric Restrictive Procedure | Number of Participants With Adverse Events | No Adverse Events | 13 Participants |
Secondary
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)
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endoscopic Gastric Restrictive Procedure | BMI Loss (kg/m^2) | 6.1 kg/m^2 |
Secondary
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.
Time frame: 12 months
Population: Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.
| Arm | Measure | Value |
|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Durability | 0 |
Secondary
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
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Percentage of Total Body Weight Loss | 18.1 Percentage of total weight lost |
Secondary
Percent Excess Weight Loss
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Percent Excess Weight Loss | 70.8 Percentage of excess weight lost |
Secondary
Waist Circumference Loss (cm)
Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
Time frame: 12 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Endoscopic Gastric Restrictive Procedure | Waist Circumference Loss (cm) | 16 cm |