Status:
UNKNOWN
vBloc Now - Registry
Lead Sponsor:
ReShape Lifesciences
Conditions:
Obesity, Morbid
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational, case series registry which will collect information pertaining to experiences and health economics in individuals implanted with vBloc Therapy who are conjunctive...
Detailed Description
The vBloc is a neuromodulation system that consists of the following implantable and external components: * Implantable components: Two leads (including one electrode each for the anterior and poster...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
December 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03434522
Start Date
December 27 2017
End Date
May 31 2019
Last Update
July 26 2018
Active Locations (2)
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1
Sky Ridge
Lone Tree, Colorado, United States, 80124
2
Christiana Institute of Advanced Surgery
Newark, Delaware, United States, 19713