vBloc Now - Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03434522|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment|
|Obesity, Morbid||Device: vBloc Maestro Rechargeable System|
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 :||Observational|
|Actual Enrollment :||125 participants|
|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|
- 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.
- Real world experiences [ Time Frame: 12 months following implant ]health data pertaining to weight and obesity comorbidities
- Health economics [ Time Frame: 12 months following implant ]Collecting data to examine quality of life and work productivity after implant
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
|United States, Colorado|
|Lone Tree, Colorado, United States, 80124|
|United States, Delaware|
|Christiana Institute of Advanced Surgery|
|Newark, Delaware, United States, 19713|