- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03918564
ReShape Vest™ for the Treatment of Obesity (Europe)
February 20, 2020 updated by: ReShape Lifesciences
An Investigative, Prospective, Non-randomized, Multi-center Study to Assess the Safety and Effectiveness of a Novel Gastric Restrictive Device, Call the ReShape Vest™, in People Who Are Obese.
To assess the safety and effectiveness of the LGV in treating obese subjects with a BMI of 35 kg/m2 to 55 kg/m2 who have failed one or more conservative weight-reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
65
Phase
- Phase 2
- Phase 3
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
-
-
-
Barcelona, Spain
- Recruiting
- Hospital Universitario de Bellvitge
-
Contact:
- Javier Osorio, MD
-
Principal Investigator:
- Jordi Pujol, MD
-
Sub-Investigator:
- Javier Osorio, MD
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Obesity class II and III (Body mass index (BMI) ≥ 35 kg/m2 to ≤55 kg/m2);
- Failed one or more conservative weight-reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s) within the last five years;
- Able to comprehend, follow and give signed informed consent;
- Reside within a reasonable distance from the Investigator's treating office and able and willing to travel to the Investigator's office to complete all routine follow-up visits;
- Ability to comply with all study requirements for the duration of the study, as outlined in the protocol, willing to submit to significant lifestyle changes that include diet, eating and exercise habits for the duration of the clinical study;
Females of childbearing potential (FOCBP) must be willing to avoid pregnancy throughout the duration of the study, including follow-up, and must agree to the following:
- have a negative serum pregnancy test as screening,
- negative urine pregnancy test day of implant,
- and inform the investigator immediately if the subject becomes pregnant;
- Willing to abstain from illegal drugs, including marijuana and tobacco (all forms) during study participation;
- Willing to limit alcohol consumption following the opinion of the Science Group of the European Alcohol and Health Forum of the European Commission;
- Has as stable concomitant medication regimen at the time of screening to mitigate drug induced weight fluctuations. A stable regimen is defined as 90 days without the introduction of or change in medication;
- Agrees to refrain from any type of reconstructive surgery/procedures that would affect body weight (such as abdominal lipoplasty or liposuction, mammoplasty, removal of excess skin or cool sculpting) during the follow-up period after the placement of the LGV.
Exclusion Criteria:
- Genetically-caused obesity, such as Prader-Willi syndrome; or any disease state know to affect weight status such as Cushing's syndrome, untreated sleep apnea, inadequately treated thyroid disease;
- History of chronic and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract, i.e. Gastroparesis and Inflammatory Bowel Diseases such as Ulcerative Colitis and Crohn's disease;
- Any abnormal stenosis or obstruction of the GI tract;
- Significant acute and/or chronic active infection including H. pylori and urinary tract infection;
- History, or signs and/or symptoms of acid-peptic disease (APD) or gastric or duodenal ulcer;
- Diagnosis of portal hypertension, cirrhosis and esophageal varices;
- Presence of renal or liver disease defined as estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m2, ALT or AST > 2x upper limit normal (ULN) or total bilirubin >1.5x ULN;
- Previous stomach or bowel surgery;
- Previous bariatric procedure or device including, but not limited to, intragastric balloons within the past twelve months, sleeve gastrectomy, endoluminal suturing and restrictive bands;
- History of adhesive peritonitis;
- Presence of a hiatal hernia greater than 3 cm;
- History of bleeding disorders such as hemophilia;
- Unable to tolerate abstinence from blood thinners, such as warfarin, during the peri-operative period;
- Anemia defined as either: Hemoglobin (Hb) value for females of <11.0 g/dl, for males <12.0 g/dl;
- Abnormal blood cell indices deemed to be clinically significant;
- Diabetes requiring insulin at baseline (Type 1 or uncontrolled Type 2 defined as an HbA1c >12%) or a significant likelihood of requiring insulin treatment in the following 24 months;
- History or known allergies to silicone or similar materials;
- Participation in other investigational study protocols. If a subject has recently completed participation in another drug or device study, the subject must have exited that study at least 90 days prior to being enrolled in this study. If a subject screen failed prior to receiving study intervention the subject may participate in the study;
- Concomitant use of (or within 90 days of screening), or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study;
- Undergoing chronic steroid or immunosuppressive therapy, defined as use of any oral and/or injectable steroid of any dose within 90 days of screening;
- Smoking cessation within two years of study entry;
- Major abdominal surgery (other than appendectomy, cholecystectomy);
- Significant traumatic injury to the abdomen within 90 days prior to enrollment;
- Subjects or immediate family members (e.g., biological parents, children, grandparents) with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease such as systemic lupus erythematosus or scleroderma;
- Current use of medications known to cause metabolic disturbances, such as the antipsychotic agents olanzapine, quetiapine, and type 2 diabetes medication thiazolidinedione (TZD);
- Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID) which is defined as daily use for greater than one month (daily low dose aspirin is acceptable);
- History or presence of malignancy such as cancer within the last five years with the exception of successfully treated non-melanoma skin cancer;
- Any condition that, in the opinion of the Investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
%Excess Weight Loss
Time Frame: 12 Months
|
Demonstrate at least 30% excess weight loss (%EWL)
|
12 Months
|
Rate of Related Serious Adverse Events
Time Frame: 12 Months
|
Evaluate safety by device and procedure-related serious adverse events
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Related Serious Adverse Events
Time Frame: 24 months
|
To evaluate the device and procedure-related serious adverse event rate
|
24 months
|
%Excess Weight Loss (EWL)
Time Frame: 24 Months
|
To demonstrate the maintenance of at least 30% EWL
|
24 Months
|
Percentage of Subjects With >=40% Excess Weight Loss (EWL)
Time Frame: 24 Months
|
To demonstrate at least 40% EWL for at least 40% of subjects compared to baseline
|
24 Months
|
Percentage of Subjects With >=50% Excess Weight Loss (EWL)
Time Frame: 24 Months
|
To demonstrate at least 50% EWL for at least 35% of subjects compared to baseline
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dov Gal, 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 (Actual)
March 25, 2019
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
April 15, 2019
First Submitted That Met QC Criteria
April 15, 2019
First Posted (Actual)
April 17, 2019
Study Record Updates
Last Update Posted (Actual)
February 24, 2020
Last Update Submitted That Met QC Criteria
February 20, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDURE II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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