The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol

Status unconfirmed · Not applicable

Conditions studied: Obesity, Morbid

In brief

This is a five-year, single arm, multi-center trial to evaluate the long-term safety and efficacy of the Maestro Rechargeable System in treating obesity. The study will include an observational arm and a randomized sub-study.

Key facts

Study ID

NCT03145636

Run by

ReShape Lifesciences

People needed

4

Starts

2017-08-30

Expected to finish

2024-12-01

Last updated by the study team

2019-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid conditions
• Females or males. Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
• At least 18 years of age
• Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last five years
• Ability to complete all study visits and procedures

You may not qualify if…

• Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.
• Patients with a large (>5cm) symptomatic hiatal hernia
• Patients for whom magnetic resonance imaging (MRI) is planned
• Patients at high risk for surgical complications
• Patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators)
• Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned Note: Diathermy is any treatment that uses high-frequency electromagnetic radiation, electric currents, or ultrasonic waves to produce heat in body tissues. Patients absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic ultrasound diathermy device whether or not it is used to produce heat. These treatments should not be applied anywhere on the body.
• Current medical condition that, in the opinion of the investigator, would make the subject unfit for surgery or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or serious trauma.
• Recent cessation of cigarette smoking (prior 2 months)
• History of bariatric surgery, Nissen fundoplication, gastric resection, major upper-abdominal surgery, or other abdominal procedures at the discretion of the investigator (acceptable surgeries include cholecystectomy or hysterectomy)
• Patients with recent (<2 years) or current history of illicit drug abuse
• Patients with significant psychiatric disease including borderline personality disorder, psychosis, schizophrenia, unstable depression, suicidal ideation, or mental retardation

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• Winthrop University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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