NCT03434522

vBloc Now - Registry

vBloc Now - A Prospective Observational Registry on the Maestro Rechargeable System (vBloc Therapy)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-27
• Primary completion: 2019-02-01
• Completion: 2019-05-31
• First posted: 2018-02-15
• Last updated: 2018-07-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study