ObesityReShapePASNCT02927665
A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
An observational study of Obesity, run by ReShape Lifesciences at 14 sites in United States.
Trial summary
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Reshape Integrated Dual Balloon
- Type of treatment
- Medical device
- How many people
- 186 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Barrington Surgeons
Barrington, Illinois, 60010
JourneyLite Physicians
Cincinnati, Ohio, 45241
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
Gastrointestinal Associates, P.C.
Knoxville, Tennessee, 37909
The Gastro Clinic
Lafayette, Louisiana, 70503
MidSouth Bariatrics
Memphis, Tennessee, 38120
Surgical Specialist of Louisiana
Metairie, Louisiana, 70001
Christiana Institute of Advanced Surgery
Newark, Delaware, 19713
New York Bariatric Group
Roslyn Heights, New York, 11577
Salem General Surgery
Salem, Ohio, 44460
Sage Bariatric Institute
San Antonio, Texas, 78240
Eviva
Shoreline, Washington, 98155
Washington University
St Louis, Missouri, 63110
North Jersey Laparoscopic Associates
Teaneck, New Jersey, 07666
About this study
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.
Read the 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.
- Conditions
- Obesity
- Being tested
- Reshape Integrated Dual Balloon
- Keywords
- Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reshape Integrated Dual BalloonDevice
Also called Reshape Integrated Dual Balloon System
| Study group | Role | What they receive |
|---|---|---|
| Study Subjects | Eligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting Receives: Device: Reshape Integrated Dual Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ReShape Dual Balloon Treatment
Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Shikora, Study director, ReShape Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927665
- Sponsor's protocol ID
- ReShape Post Approval Study
- Acronym
- ReShapePAS
- Status last verified
- Mar 2019
- First submitted
- 5 Oct 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
- ClinicalTrials.gov ID
- NCT02927665
- Acronym / sponsor ID
- ReShapePAS / ReShape Post Approval Study
- Conditions
- Obesity
- Keywords
- Weight Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | – | Device: Reshape Integrated Dual BalloonEligible subjects receiving ReShape Integrated Dual Balloon System treatment in a commercial clinical setting |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reshape Integrated Dual BalloonAlso: Reshape Integrated Dual Balloon System | Device | Study Subjects |
Primary outcome
Safety of ReShape Dual Balloon Treatment
Time frame: 24 weeks
Safety of ReShape Dual Balloon Treatment using a composite endpoint consisting of all device- and/or procedure-related SAEs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Shikora study director
ReShape Lifesciences
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by ReShape Lifesciences at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ReShape Dual Balloon Treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.