Trial Outcomes & Findings for The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity (NCT NCT01327976)
NCT ID: NCT01327976
Last Updated: 2017-08-30
Results Overview
To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
239 participants
Primary outcome timeframe
12 months
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
vBloc (Active Device)
The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy.
|
Sham (Non-active Device)
The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
77
|
|
Overall Study
COMPLETED
|
154
|
70
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
Baseline characteristics by cohort
| Measure |
vBloc (Active Device)
n=162 Participants
The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy.
|
Sham (Non-active Device)
n=77 Participants
The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
162 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 10 • n=99 Participants
|
47 years
STANDARD_DEVIATION 9 • n=107 Participants
|
47 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=99 Participants
|
60 participants
n=107 Participants
|
182 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
40 participants
n=99 Participants
|
17 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: An intent-to-treat analysis was performed in the vBloc group.
To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
Outcome measures
| Measure |
vBloc (Active Device)
n=162 Participants
The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
|
Sham (Non-active Device)
n=77 Participants
The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
|
|---|---|---|
|
Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).
|
3.7 percentage of participants
Interval 1.4 to 7.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 12 monthsObserve at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).
Outcome measures
| Measure |
vBloc (Active Device)
n=162 Participants
The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
|
Sham (Non-active Device)
n=77 Participants
The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
|
|---|---|---|
|
Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.
|
24.4 percentage of excess weight loss
Interval 20.8 to 28.1
|
15.9 percentage of excess weight loss
Interval 11.9 to 19.9
|
PRIMARY outcome
Timeframe: 12 monthsThe second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.
Outcome measures
| Measure |
vBloc (Active Device)
n=162 Participants
The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
|
Sham (Non-active Device)
n=77 Participants
The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
|
|---|---|---|
|
Percentage Responder Rate in the Treatment Arm.
% of subjects achieving an EWL of at least 20%
|
52.5 percentage of subjects
|
32.5 percentage of subjects
|
|
Percentage Responder Rate in the Treatment Arm.
% of subjects achieving an EWL of at least 25%
|
38.3 percentage of subjects
|
23.4 percentage of subjects
|
Adverse Events
vBloc (Active Device)
Serious events: 26 serious events
Other events: 128 other events
Deaths: 0 deaths
Sham (Non-active Device)
Serious events: 4 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
vBloc (Active Device)
n=162 participants at risk
The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy.
|
Sham (Non-active Device)
n=77 participants at risk
The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy.
|
|---|---|---|
|
Surgical and medical procedures
Neuroregulator malfunction
|
1.2%
2/162 • Number of events 2 • 1 year
|
0.00%
0/77 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Hepatobiliary disorders
Gallbladder disease
|
1.2%
2/162 • Number of events 2 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Emesis/vomiting
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pain, neuroregulator site
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
3.7%
6/162 • Number of events 6 • 1 year
|
0.00%
0/77 • 1 year
|
|
Hepatobiliary disorders
Cirrhosis
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Generalized ileus
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Blood and lymphatic system disorders
Intra-operative oozing
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
General disorders
Allergic reaction
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
General disorders
Chest pain
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/162 • 1 year
|
1.3%
1/77 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection, other
|
0.62%
1/162 • Number of events 1 • 1 year
|
1.3%
1/77 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Gastrointestinal disorders
Pain, abdominal
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
General disorders
Pain, other
|
1.2%
2/162 • Number of events 2 • 1 year
|
0.00%
0/77 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.62%
1/162 • Number of events 1 • 1 year
|
0.00%
0/77 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/162 • 1 year
|
1.3%
1/77 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Worsening back pain
|
0.00%
0/162 • 1 year
|
1.3%
1/77 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
vBloc (Active Device)
n=162 participants at risk
The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy.
|
Sham (Non-active Device)
n=77 participants at risk
The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.
Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain, neuroregulator site
|
40.1%
65/162 • Number of events 78 • 1 year
|
41.6%
32/77 • Number of events 37 • 1 year
|
|
General disorders
Other
|
55.6%
90/162 • Number of events 157 • 1 year
|
51.9%
40/77 • Number of events 62 • 1 year
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
25.9%
42/162 • Number of events 46 • 1 year
|
5.2%
4/77 • Number of events 4 • 1 year
|
|
General disorders
Pain, other
|
49.4%
80/162 • Number of events 136 • 1 year
|
36.4%
28/77 • Number of events 36 • 1 year
|
|
Gastrointestinal disorders
Pain, abdominal
|
15.4%
25/162 • Number of events 32 • 1 year
|
2.6%
2/77 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
14/162 • Number of events 14 • 1 year
|
1.3%
1/77 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Eructation/belching
|
8.0%
13/162 • Number of events 13 • 1 year
|
0.00%
0/77 • 1 year
|
|
Surgical and medical procedures
Incision pain
|
7.4%
12/162 • Number of events 13 • 1 year
|
9.1%
7/77 • Number of events 7 • 1 year
|
|
General disorders
Chest pain
|
6.2%
10/162 • Number of events 10 • 1 year
|
3.9%
3/77 • Number of events 4 • 1 year
|
|
Skin and subcutaneous tissue disorders
Wound redness or irritation
|
4.3%
7/162 • Number of events 7 • 1 year
|
6.5%
5/77 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cold/flu/respiratory tract infection
|
43.2%
70/162 • Number of events 121 • 1 year
|
42.9%
33/77 • Number of events 58 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
14.8%
24/162 • Number of events 24 • 1 year
|
16.9%
13/77 • Number of events 15 • 1 year
|
|
General disorders
Headache
|
13.0%
21/162 • Number of events 24 • 1 year
|
10.4%
8/77 • Number of events 9 • 1 year
|
|
Metabolism and nutrition disorders
Out of range lab values
|
12.3%
20/162 • Number of events 23 • 1 year
|
7.8%
6/77 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
18/162 • Number of events 19 • 1 year
|
5.2%
4/77 • Number of events 4 • 1 year
|
|
General disorders
Trauma
|
9.3%
15/162 • Number of events 19 • 1 year
|
14.3%
11/77 • Number of events 18 • 1 year
|
|
Infections and infestations
Infection, other
|
9.3%
15/162 • Number of events 18 • 1 year
|
14.3%
11/77 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
8.0%
13/162 • Number of events 15 • 1 year
|
3.9%
3/77 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Emesis/vomiting
|
6.8%
11/162 • Number of events 12 • 1 year
|
7.8%
6/77 • Number of events 6 • 1 year
|
|
General disorders
Reaction to medicines
|
6.2%
10/162 • Number of events 12 • 1 year
|
7.8%
6/77 • Number of events 6 • 1 year
|
|
Psychiatric disorders
Anxiety
|
6.8%
11/162 • Number of events 11 • 1 year
|
3.9%
3/77 • Number of events 3 • 1 year
|
|
General disorders
Dizziness
|
6.2%
10/162 • Number of events 10 • 1 year
|
3.9%
3/77 • Number of events 3 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60