Obesity, MorbidNCT03434522
vBloc Now - Registry
An observational study of Obesity, Morbid, run by ReShape Lifesciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- vBloc Maestro Rechargeable System
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sky Ridge
Lone Tree, Colorado, 80124
Christiana Institute of Advanced Surgery
Newark, Delaware, 19713
About this study
Official title: vBloc Now - A Prospective Observational Registry on the Maestro Rechargeable System (vBloc Therapy)
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.
Read the 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
- Being tested
- vBloc Maestro Rechargeable System
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vBloc Maestro Rechargeable SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Real world experiences
health data pertaining to weight and obesity comorbidities
Measured: 12 months following implant
Health economics
Collecting data to examine quality of life and work productivity after implant
Measured: 12 months following implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start27 Dec 2017
- Primary completion1 Feb 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434522
- Sponsor's protocol ID
- D01702-000
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- vBloc Now - A Prospective Observational Registry on the Maestro Rechargeable System (vBloc Therapy)
- ClinicalTrials.gov ID
- NCT03434522
- Acronym / sponsor ID
- D01702-000
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vBloc Maestro Rechargeable SystemvBloc therapy consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, to the intra-abdominal vagus nerve for the treatment of obesity. | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by ReShape Lifesciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world experiences (time frame: 12 months following implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.