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vBloc Now - Registry

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ClinicalTrials.gov Identifier: NCT03434522
Recruitment Status : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
ReShape Lifesciences

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.


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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

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.


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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434522


Locations
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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

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Responsible Party: ReShape Lifesciences
ClinicalTrials.gov Identifier: NCT03434522     History of Changes
Other Study ID Numbers: D01702-000
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms