vBloc Now - Registry

NCT03434522 | Unknown FDA Device

• 1 other identifier: D01702-000
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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 conjunctively using a weight management program. Subjects will be followed for 12 months after implant.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Real world experiences

  health data pertaining to weight and obesity comorbidities

  12 months following implant

• Health economics

  Collecting data to examine quality of life and work productivity after implant

  12 months following implant

Interventions

vBloc Maestro Rechargeable System DEVICE

vBloc therapy consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, to the intra-abdominal vagus nerve for the treatment of obesity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone 18 years of age and older with a 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.

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.

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (2)

Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Christiana Institute of Advanced Surgery

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 15, 2018
• Study Start: December 27, 2017
• Primary Completion: February 1, 2019
• Study Completion: May 31, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-02

Locations

US (2)