- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434522
vBloc Now - Registry
vBloc Now - A Prospective Observational Registry on the Maestro Rechargeable System (vBloc Therapy)
Study Overview
Status
Conditions
Intervention / Treatment
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 posterior intra-abdominal vagal nerve trunks) are implanted laparoscopically on the intra-abdominal trunks of the vagus nerve and connected to a neuroregulator, which is implanted subcutaneously on the thoracic sidewall.
- External components: A mobile charger (MC) is connected to a non-invasive transmit coil, positioned over the implanted neuroregulator and secured in place using a transmit coil belt to charge and perform status checks on the neuroregulator. The MC is charged using an AC recharger. A laptop computer (CP) with proprietary software is used to control and upload data from the neuroregulator through the MC via the programmer cable. The CP is used by the clinician to change treatment parameters and assess battery recharging compliance. A torque wrench is used during the implant procedure to secure the leads into the neuroregulator.
Schedule of events following the baseline study visit include: implant, 2 week follow up, and 1, 3, 6, 9, and 12 month follow up visits. Enrolled subjects will also use the vBloc Achieve weight management program, which is a remote weight management counseling sessions with a registered dietitian to discuss healthy diet and exercise habits and weight loss goals.
The vBloc Now registry, together with vBloc Therapy and the vBloc Achieve weight management program, incorporates specific diets after the implant, routine remote counseling by an experienced registered dietitian, recommendations for physical activity, and tracking of weight, food intake, and fitness. The expectation is that patients participating in the vBloc Now registry, who comply with the diet and behavioral recommendations in combination with use of the Maestro device, will see an improvement in their overall health, whether it's related to weight loss, improvements in co-morbidities, or a better quality of life.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Lone Tree, Colorado, United States, 80124
- Sky Ridge
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Delaware
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Newark, Delaware, United States, 19713
- Christiana Institute of Advanced Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Real world experiences
Time Frame: 12 months following implant
|
health data pertaining to weight and obesity comorbidities
|
12 months following implant
|
Health economics
Time Frame: 12 months following implant
|
Collecting data to examine quality of life and work productivity after implant
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12 months following implant
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D01702-000
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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