A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
NCT ID: NCT02927665
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
186 participants
OBSERVATIONAL
2016-09-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Study Subjects
Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting
Reshape Integrated Dual Balloon
Interventions
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Reshape Integrated Dual Balloon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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ReShape Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Shikora
Role: STUDY_DIRECTOR
ReShape Lifesciences
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Christiana Institute of Advanced Surgery
Newark, Delaware, United States
Barrington Surgeons
Barrington, Illinois, United States
The Gastro Clinic
Lafayette, Louisiana, United States
Surgical Specialist of Louisiana
Metairie, Louisiana, United States
Washington University
St Louis, Missouri, United States
North Jersey Laparoscopic Associates
Teaneck, New Jersey, United States
New York Bariatric Group
Roslyn Heights, New York, United States
JourneyLite Physicians
Cincinnati, Ohio, United States
Salem General Surgery
Salem, Ohio, United States
Gastrointestinal Associates, P.C.
Knoxville, Tennessee, United States
MidSouth Bariatrics
Memphis, Tennessee, United States
Sage Bariatric Institute
San Antonio, Texas, United States
Eviva
Shoreline, Washington, United States
Countries
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Other Identifiers
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ReShape Post Approval Study
Identifier Type: -
Identifier Source: org_study_id
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