Clinical trial NCT02927665: A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
Official title: A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Weight Loss
Lead sponsor: ReShape Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 186
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients with a body mass index (BMI) of 30-40 and one or more obesity-related comorbid conditions, who have failed weight reduction with diet and exercise alone

Brief summary: The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.

Detailed description: The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label clinical study intended to collect valid scientific evidence regarding the safety and efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial clinical setting.

Eligibility criteria: Inclusion Criteria:

1. Ages 22 and older
2. Baseline BMI 30 - 40
3. Failed weight reduction with diet and exercise alone
4. One or more obesity-related comorbid conditions
5. If female of child bearing potential, willing to avoid pregnancy during course of treatment

Exclusion Criteria:

1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
2. Prior open or laparoscopic bariatric surgery.
3. Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
4. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
5. A gastric mass.
6. A hiatal hernia \> 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
9. Severe coagulopathy
10. Hepatic insufficiency or cirrhosis
11. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
12. Alcoholism or drug addiction.
13. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
14. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
15. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
16. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
17. Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect the levels of serotonin in the body \[e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)\] should not undergo placement of the device.
18. Patients who are pregnant or breast-feeding.
19. Significant endoscopic abnormalities immediately prior to device insertion.

Primary outcomes:
measure: Safety of ReShape Dual Balloon Treatment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Newark
country: United States
facility: Christiana Institute of Advanced Surgery
state: Delaware
city: Barrington
country: United States
facility: Barrington Surgeons
state: Illinois
city: Lafayette
country: United States
facility: The Gastro Clinic
state: Louisiana
city: Metairie
country: United States
facility: Surgical Specialist of Louisiana
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Teaneck
country: United States
facility: North Jersey Laparoscopic Associates
state: New Jersey
city: Roslyn Heights
country: United States
facility: New York Bariatric Group
state: New York
city: Cincinnati
country: United States
facility: JourneyLite Physicians
state: Ohio
city: Salem
country: United States
facility: Salem General Surgery
state: Ohio
city: Knoxville
country: United States
facility: Gastrointestinal Associates, P.C.
state: Tennessee
city: Memphis
country: United States
facility: MidSouth Bariatrics
state: Tennessee
city: San Antonio
country: United States
facility: Sage Bariatric Institute
state: Texas
city: Shoreline
country: United States
facility: Eviva
state: Washington
Study officials:
affiliation: ReShape Lifesciences
name: Scott Shikora
role: STUDY_DIRECTOR
References: