vBloc Now - Registry

• ClinicalTrials.gov Identifier: NCT03434522
• Recruitment Status: Unknown
• First Posted: February 15, 2018
• Last Update Posted: July 26, 2018
• Sponsor: ReShape Lifesciences
• Information provided by (Responsible Party): ReShape Lifesciences

Study Description

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.

Condition or disease	Intervention/treatment
Obesity, Morbid	Device: vBloc Maestro Rechargeable System

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 Design

• Study Type: Observational
• Actual Enrollment: 125 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: vBloc Now - A Prospective Observational Registry on the Maestro Rechargeable System (vBloc Therapy)
• Actual Study Start Date: December 27, 2017
• Estimated Primary Completion Date: February 1, 2019
• Estimated Study Completion Date: May 31, 2019

Groups and Cohorts

Intervention Details:

• Device: vBloc Maestro Rechargeable System
  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.

Outcome Measures

Primary Outcome Measures :

1. Real world experiences [ Time Frame: 12 months following implant ]
   health data pertaining to weight and obesity comorbidities
2. Health economics [ Time Frame: 12 months following implant ]
   Collecting data to examine quality of life and work productivity after implant

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

Inclusion criteria

1. Signed informed consent
2. 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
3. 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.
4. At least 18 years of age
5. Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last five years
6. Ability to complete all study visits and procedures

Exclusion criteria

1. Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.
2. Patients with a large (>5cm) symptomatic hiatal hernia
3. Patients for whom magnetic resonance imaging (MRI) is planned
4. Patients at high risk for surgical complications
5. Patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators)
6. 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.
7. 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.

Contacts and Locations

Locations

United States, Colorado

Sky Ridge

Lone Tree, Colorado, United States, 80124

United States, Delaware

Christiana Institute of Advanced Surgery

Newark, Delaware, United States, 19713

Sponsors and Collaborators

ReShape Lifesciences

More Information

• Responsible Party: ReShape Lifesciences
• ClinicalTrials.gov Identifier: NCT03434522
• Other Study ID Numbers: D01702-000
• First Posted: February 15, 2018
• Last Update Posted: July 26, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight