- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927665
A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects (ReShapePAS)
March 28, 2019 updated by: ReShape Lifesciences
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
186
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Dothan, Alabama, United States, 36305
- Digestive Health Specialists of the Southeast
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Delaware
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Newark, Delaware, United States, 19713
- Christiana Institute of Advanced Surgery
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Illinois
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Barrington, Illinois, United States, 60010
- Barrington Surgeons
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Louisiana
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Lafayette, Louisiana, United States, 70503
- The Gastro Clinic
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Metairie, Louisiana, United States, 70001
- Surgical Specialist of Louisiana
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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New Jersey
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Teaneck, New Jersey, United States, 07666
- North Jersey Laparoscopic Associates
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New York
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Roslyn Heights, New York, United States, 11577
- New York Bariatric Group
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Ohio
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Cincinnati, Ohio, United States, 45241
- JourneyLite Physicians
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Salem, Ohio, United States, 44460
- Salem General Surgery
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Gastrointestinal Associates, P.C.
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Memphis, Tennessee, United States, 38120
- MidSouth Bariatrics
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Texas
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San Antonio, Texas, United States, 78240
- Sage Bariatric Institute
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Washington
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Shoreline, Washington, United States, 98155
- Eviva
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Ages 22 and older
- Baseline BMI 30 - 40
- Failed weight reduction with diet and exercise alone
- One or more obesity-related comorbid conditions
- If female of child bearing potential, willing to avoid pregnancy during course of treatment
Exclusion Criteria:
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions
- Prior open or laparoscopic bariatric surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- 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.
- A gastric mass.
- A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
- 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.
- Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
- Severe coagulopathy
- Hepatic insufficiency or cirrhosis
- 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.
- Alcoholism or drug addiction.
- Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
- 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.
- Patients who are pregnant or breast-feeding.
- Significant endoscopic abnormalities immediately prior to device insertion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Study Subjects
Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of ReShape Dual Balloon Treatment
Time Frame: 24 weeks
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Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Scott Shikora, ReShape Lifesciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
November 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
October 5, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ReShape Post Approval Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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