Trial Outcomes & Findings for EMPOWER Clinical Trial: Vagal Blocking for Obesity Control (NCT NCT00521079)
NCT ID: NCT00521079
Last Updated: 2018-08-24
Results Overview
Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
294 participants
Primary outcome timeframe
Baseline and 1 Year
Results posted on
2018-08-24
Participant Flow
Participant milestones
| Measure |
vBloc
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
102
|
|
Overall Study
Surgical Roll-In
|
9
|
5
|
|
Overall Study
COMPLETED
|
178
|
97
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
Reasons for withdrawal
| Measure |
vBloc
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
Baseline characteristics by cohort
| Measure |
vBloc
n=183 Participants
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=97 Participants
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
183 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=5 Participants
|
77 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
41 participants
n=5 Participants
|
20 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 YearObserve at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Outcome measures
| Measure |
vBloc
n=165 Participants
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=88 Participants
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
|---|---|---|
|
Percentage of Excess Weight Loss (EWL) With the Maestro System
|
17 Percentage of excess weight loss
Standard Error 2
|
16 Percentage of excess weight loss
Standard Error 2
|
PRIMARY outcome
Timeframe: 1 YearTo estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
Outcome measures
| Measure |
vBloc
n=192 Participants
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=102 Participants
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
|---|---|---|
|
Rate of System and Procedure-related Serious Adverse Events (SAEs).
|
6 Events
|
3 Events
|
SECONDARY outcome
Timeframe: Baseline and 1 YearTo evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.
Outcome measures
| Measure |
vBloc
n=183 Participants
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=97 Participants
Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
|
|---|---|---|
|
Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)
|
22 Percentage of subjects
|
25 Percentage of subjects
|
Adverse Events
vBloc
Serious events: 23 serious events
Other events: 146 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
vBloc
n=192 participants at risk
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=102 participants at risk
Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
|
|---|---|---|
|
Surgical and medical procedures
Incision pain incision site
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Infections and infestations
Infection neuroregulator site
|
1.0%
2/192 • Number of events 2
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
Surgical and medical procedures
Lead impedance high
|
0.00%
0/192
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
Surgical and medical procedures
Neuroregulator malfunction
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Pain abdominal
|
1.6%
3/192 • Number of events 3
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Skin and subcutaneous tissue disorders
Pain neuroregulator site
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
Reproductive system and breast disorders
Bleeding other
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Cardiac disorders
Cardiac abnormality
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
General disorders
Cold/flu/respiratory tract infection
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Hepatobiliary disorders
Gallbladder disease
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/192
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
Infections and infestations
Infection other
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Large bowel dysfunction
|
0.00%
0/192
Includes roll-in subjects.
|
0.98%
1/102 • Number of events 1
Includes roll-in subjects.
|
|
General disorders
Other
|
4.2%
8/192 • Number of events 8
Includes roll-in subjects.
|
5.9%
6/102 • Number of events 6
Includes roll-in subjects.
|
|
General disorders
Pain other
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
|
General disorders
Reaction to medicines
|
0.52%
1/192 • Number of events 1
Includes roll-in subjects.
|
0.00%
0/102
Includes roll-in subjects.
|
Other adverse events
| Measure |
vBloc
n=192 participants at risk
Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
|
Placebo
n=102 participants at risk
Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
|
|---|---|---|
|
Gastrointestinal disorders
Bloating Abdominal
|
5.2%
10/192 • Number of events 10
Includes roll-in subjects.
|
6.9%
7/102 • Number of events 8
Includes roll-in subjects.
|
|
General disorders
Chest Pain
|
9.9%
19/192 • Number of events 19
Includes roll-in subjects.
|
2.0%
2/102 • Number of events 2
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
32/192 • Number of events 38
Includes roll-in subjects.
|
11.8%
12/102 • Number of events 12
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
23/192 • Number of events 29
Includes roll-in subjects.
|
14.7%
15/102 • Number of events 20
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Eructation
|
10.4%
20/192 • Number of events 22
Includes roll-in subjects.
|
9.8%
10/102 • Number of events 11
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
24.5%
47/192 • Number of events 57
Includes roll-in subjects.
|
14.7%
15/102 • Number of events 17
Includes roll-in subjects.
|
|
Surgical and medical procedures
Incision pain incision site
|
3.6%
7/192 • Number of events 7
Includes roll-in subjects.
|
7.8%
8/102 • Number of events 8
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
32/192 • Number of events 40
Includes roll-in subjects.
|
8.8%
9/102 • Number of events 9
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Pain Abdominal
|
16.7%
32/192 • Number of events 38
Includes roll-in subjects.
|
18.6%
19/102 • Number of events 22
Includes roll-in subjects.
|
|
Skin and subcutaneous tissue disorders
Pain neuroregulator site
|
21.9%
42/192 • Number of events 47
Includes roll-in subjects.
|
27.5%
28/102 • Number of events 30
Includes roll-in subjects.
|
|
General disorders
Skin reaction to coil/coil adhesion method
|
9.4%
18/192 • Number of events 21
Includes roll-in subjects.
|
7.8%
8/102 • Number of events 9
Includes roll-in subjects.
|
|
Skin and subcutaneous tissue disorders
Wound redness or irritation
|
5.7%
11/192 • Number of events 12
Includes roll-in subjects.
|
3.9%
4/102 • Number of events 5
Includes roll-in subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cold/flu/respiratory tract infection
|
48.4%
93/192 • Number of events 170
Includes roll-in subjects.
|
45.1%
46/102 • Number of events 101
Includes roll-in subjects.
|
|
Psychiatric disorders
Depression
|
12.5%
24/192 • Number of events 24
Includes roll-in subjects.
|
5.9%
6/102 • Number of events 6
Includes roll-in subjects.
|
|
General disorders
Energy decreased
|
7.3%
14/192 • Number of events 15
Includes roll-in subjects.
|
2.9%
3/102 • Number of events 3
Includes roll-in subjects.
|
|
General disorders
Headache
|
10.4%
20/192 • Number of events 22
Includes roll-in subjects.
|
5.9%
6/102 • Number of events 7
Includes roll-in subjects.
|
|
Cardiac disorders
Edema
|
4.7%
9/192 • Number of events 9
Includes roll-in subjects.
|
2.9%
3/102 • Number of events 3
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Emesis (vomiting)
|
10.4%
20/192 • Number of events 20
Includes roll-in subjects.
|
7.8%
8/102 • Number of events 10
Includes roll-in subjects.
|
|
Metabolism and nutrition disorders
Out of range lab values
|
4.7%
9/192 • Number of events 9
Includes roll-in subjects.
|
2.9%
3/102 • Number of events 3
Includes roll-in subjects.
|
|
Metabolism and nutrition disorders
Vitamin or mineral insufficiency
|
7.3%
14/192 • Number of events 18
Includes roll-in subjects.
|
5.9%
6/102 • Number of events 8
Includes roll-in subjects.
|
|
Gastrointestinal disorders
Cramps abdominal
|
4.2%
8/192 • Number of events 8
Includes roll-in subjects.
|
5.9%
6/102 • Number of events 7
Includes roll-in subjects.
|
|
General disorders
Reaction to medicines
|
4.7%
9/192 • Number of events 10
Includes roll-in subjects.
|
4.9%
5/102 • Number of events 5
Includes roll-in subjects.
|
|
Renal and urinary disorders
Urinary tract infection
|
7.3%
14/192 • Number of events 15
Includes roll-in subjects.
|
8.8%
9/102 • Number of events 13
Includes roll-in subjects.
|
|
Psychiatric disorders
Anxiety
|
2.6%
5/192 • Number of events 7
Includes roll-in subjects.
|
4.9%
5/102 • Number of events 5
Includes roll-in subjects.
|
|
Musculoskeletal and connective tissue disorders
Trauma
|
4.2%
8/192 • Number of events 11
Includes roll-in subjects.
|
8.8%
9/102 • Number of events 12
Includes roll-in subjects.
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
2.1%
4/192 • Number of events 4
Includes roll-in subjects.
|
4.9%
5/102 • Number of events 5
Includes roll-in subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60