ReShape Vest™ for the Treatment of Obesity (Europe)

NCT03918564 | Unknown Phase 2 DMC

• 1 other identifier: ENDURE II
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity; Weight Loss

Keywords

Weightloss

Outcome Measures

Primary Outcomes (2)

• %Excess Weight Loss

  Demonstrate at least 30% excess weight loss (%EWL)

  12 Months

• Rate of Related Serious Adverse Events

  Evaluate safety by device and procedure-related serious adverse events

  12 Months

Secondary Outcomes (4)

• Rate of Related Serious Adverse Events

  24 months

• %Excess Weight Loss (EWL)

  24 Months

• Percentage of Subjects With >=40% Excess Weight Loss (EWL)

  24 Months

• Percentage of Subjects With >=50% Excess Weight Loss (EWL)

  24 Months

Interventions

Laparoscopic Gastric Vest (LGV) DEVICE

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).

Also known as: ReShape Vest™

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (1)

Hospital universitario de Bellvitge

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Dov Gal

  ReShape Lifesciences

  STUDY DIRECTOR

Central Study Contacts

Alina Stoica

CONTACT

949-276-4310; astoica@reshapelifesci.com

Kristin Wielenga

CONTACT

949-481-7851; kwielenga@reshapelifesci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: March 25, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)