ObesityPhase 2/3NCT03918564
ReShape Vest™ for the Treatment of Obesity (Europe)
A Phase 2/3 study testing Laparoscopic Gastric Vest (LGV) in people with Obesity and Weight Loss, run by ReShape Lifesciences at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Laparoscopic Gastric Vest (LGV)
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2019to Dec 2021
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital universitario de Bellvitge
Barcelona
Javier Osorio, MD
Jordi Pujol, MD
About this study
Official title: 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).
- Conditions
- Obesity, Weight Loss
- Being tested
- Laparoscopic Gastric Vest (LGV)
- Keywords
- Weightloss
- 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.
Laparoscopic Gastric Vest (LGV)Device
Also called ReShape Vest™
The Laparoscopic Gastric Vest (LGV), branded the ReShape Vest™, is a long-term, silastic, implantable system that is placed around the stomach to encompass the gastroesophageal junction to the Incisura Angularis.
The main materials used to make the LGV is Implant Grade Silicone (95%) and Barium Sulfate (5%).
The LGV is indicated for weight reduction for obese people with a Body Mass Index (BMI) between ≥35 kg/m2 and ≤55 kg/m2. It is indicated for use in adult patients (≥22 to ≤65 years) who have failed one or more conservative weight reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s).
What is being measured
The primary outcome is the main question the study is designed to answer.
%Excess Weight Loss
Demonstrate at least 30% excess weight loss (%EWL)
Measured: 12 Months
Rate of Related Serious Adverse Events
Evaluate safety by device and procedure-related serious adverse events
Measured: 12 Months
Secondary outcomes (4)
Rate of Related Serious Adverse Events
To evaluate the device and procedure-related serious adverse event rate
Measured: 24 months
%Excess Weight Loss (EWL)
To demonstrate the maintenance of at least 30% EWL
Measured: 24 Months
Percentage of Subjects With >=40% Excess Weight Loss (EWL)
To demonstrate at least 40% EWL for at least 40% of subjects compared to baseline
Measured: 24 Months
Percentage of Subjects With >=50% Excess Weight Loss (EWL)
To demonstrate at least 50% EWL for at least 35% of subjects compared to baseline
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start25 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dov Gal, Study director, ReShape Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918564
- Sponsor's protocol ID
- ENDURE II
- Status last verified
- Feb 2020
- First submitted
- 15 Apr 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03918564
- Acronym / sponsor ID
- ENDURE II
- Conditions
- Obesity, Weight Loss
- Keywords
- Weightloss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Apr 2019 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (28 listed)
- 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;
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 |
|---|---|---|
| Laparoscopic Gastric Vest (LGV)Also: ReShape Vest™The Laparoscopic Gastric Vest (LGV), branded the ReShape Vest™, is a long-term, silastic, implantable system that is placed around the stomach to encompass the gastroesophageal junction to the Incisura Angularis. The main materials used to make the LGV is Implant Grade Silicone (95%) and Barium Sulfate (5%). The LGV is indicated for weight reduction for obese people with a Body Mass Index (BMI) between ≥35 kg/m2 and ≤55 kg/m2. It is indicated for use in adult patients (≥22 to ≤65 years) who have failed one or more conservative weight reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s). | Device | – |
Primary outcome
%Excess Weight Loss
Time frame: 12 Months
Demonstrate at least 30% excess weight loss (%EWL)
Rate of Related Serious Adverse Events
Time frame: 12 Months
Evaluate safety by device and procedure-related serious adverse events
4 secondary outcomes
Rate of Related Serious Adverse Events
Time frame: 24 months
%Excess Weight Loss (EWL)
Time frame: 24 Months
Percentage of Subjects With >=40% Excess Weight Loss (EWL)
Time frame: 24 Months
Percentage of Subjects With >=50% Excess Weight Loss (EWL)
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- 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.
Dov Gal study director
ReShape Lifesciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Laparoscopic Gastric Vest (LGV) in people with Obesity and Weight Loss, run by ReShape Lifesciences at 1 site in Spain.
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 13 inclusion and 28 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alina Stoica (949-276-4310, astoica@reshapelifesci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%Excess Weight Loss (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 24 Feb 2020.