|
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P130019 / PAS002 |
| Date Original Protocol Accepted |
07/24/2015
|
| Date Current Protocol Accepted |
01/24/2018
|
| Study Name |
New Enrollment Study
|
| Device Name |
MAESTRO RECHARGEABLE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this PAS is to evaluate the long-term safety and effectiveness of Maestro.
This is a prospective, multi-center, new enrollment study. The study will include an observational arm and a randomized sub-study. Subjects in the observational arm will receive the device implant and use the vBloc Achieve weight management program.
The randomized sub-study will randomly assign subjects (1:1) to either treatment or control. Subjects assigned to the treatment arm of the randomized sub-study will receive
the device implant and use the vBloc Achieve weight management program. Subjects who are randomized to the control arm of the randomized sub-study will participate in a Control Weight Management (CWM) program during a 6-month control period prior to receiving the device implant and using the vBloc Achieve program. The vBloc Achieve weight management program consists of recommendations regarding
diet, exercise, and behavior modification, and will be utilized be all subjects following their device implantation.
|
| Study Population |
Patients at least 18 years old who have a BMI of 40-45 kg/m2, or a BMI of 35-39.9 kg/m2 with 1 or more obesity related comorbidities and have failed at least 1 supervised weight management program in the past 5 years. There is no control group in this study.
|
| Sample Size |
200 total subjects with obesity will be implanted with the Maestro Rechargeable System at a minimum of 10 and a maximum of 15 sites.
100 of the subjects will be implanted in an observational portion of the study. 100 subjects will be implanted in a randomized sub-study. Subjects enrolled in the randomized substudy will be randomized 1:1 to either treatment or control arms as described in this protocol.
It is anticipated that approximately 120 subjects will have complete follow-up data at the 5-year visit. 200 subjects with an approximate 8% of attrition per year will provide at least 90% statistical power for the powered 5-year safety objective.
|
| Key Study Endpoints |
The main study endpoint is the 5-year rate of SAEs related to the device, implant/revision procedure (including explant procedure), general surgical procedure, or therapy. Other study endpoints include: weight loss measured by %TBL and %EWL; change in obesity-related comorbidities (blood pressure, waist circumference and the number, type and dose of medications for treatment of diabetes, hypertension and dyslipidemia); surgical revision, surgical explant, device explants specifically to undergo MRI, therapy-related AEs, and device (neuroregulator or lead) malfunction requiring a revision procedure; and AEs involving lead breakage/fracture, twisting/entanglement, replacement, lead erosion, and bowel/tissue obstruction.
|
| Follow-up Visits and Length of Follow-up |
200 subjects enrolled at a minimum of 10 and a maximum of 15 sites
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
4 patients out of 200 that were expected to be enrolled
|
| Actual Number of Sites Enrolled |
2
|
| Patient Follow-up Rate |
3 out of 4 enrolled patients
|
| Final Safety Findings |
There was one (1) unrelated SAE of breast cancer that occurred among the 3 patients that were followed. There were three (3) related AEs among two (2) subjects that included burning at the neuroregulator site, left shoulder soreness and bleeding.
|
| Final Effect Findings |
The mean % of total body weight loss (TBL) among the three (3) patients who reached 15 months, was 10.49%.
Among these three (3) patients, 2 of them met a > 10%TBL.
The mean change in systolic blood pressure among the three (3) patients being followed was -12.00 (SD: 7.535)
at 12 months. At the same interval for the three (3) patients, the diastolic blood pressure increased by 4.44
(SD: 7.128). The pulse rate at 12 months decreased by - 11.33 (SD: 19.348).
Although it was decrease in systolic BP at 12 months. At the same interval, the diastolic BP slightly increased.
The pulse rate decreased at 9 and 12 months, as well as at trail exit, but not at 15 or 18 months of follow-up.
The differences in the magnitude and direction from increase to decrease in these measurements make
impossible to evaluate the impact of treatment on the pulse and blood pressure in these three (3) patients.
The waist and hip circumference were reduced when assessed at 6 and 12 months. However, these
reductions were assessed in two patients at 6 months and in three (3) patients at 12 months.
|
| Study Strengths & Weaknesses |
No strengths. The weaknesses include an inadequate progress including small sample size, poor follow-up, and early
termination of the study. The study enrolled two (2) out of 20 sites that were expected and four (4) out of 200 expected
patients as per approved protocol. From the four (4) enrolled study subjects one (1) of them was followed for 18 months, two
(2) more for one year and the other patient dropped out.
|
| Recommendations for Labeling Changes |
None
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