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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130019 / PAS001 |
| Date Original Protocol Accepted |
06/02/2015
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| Date Current Protocol Accepted |
02/15/2019
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| Study Name |
Extended F/u of Premarket Cohort
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| Device Name |
MAESTRO RECHARGEABLE SYSTEM
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| Clinical Trial Number(s) |
NCT01327976
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Open label crossover study from premarket cohort for VBLOC therapy. All remaining subjects either received an implanted device at randomization, have crossed over from to active device after the 12 month visit, or will crossover to the active device.
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| Study Population |
Transitional. Adolescent B (as adults) : 18-21 years, Adult: >21
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| Sample Size |
203 patients will receive VBLOC therapy. The sponsor anticipates approximately 100 subjects will have complete follow-up data at the 5-year visit.
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| Key Study Endpoints |
The primary safety objective is to show that the rate of serious adverse events (SAEs) related to the device, implant/revision procedure (including the explant procedure), general surgical procedure, or therapy algorithm is statistically lower than 25% at 5 years.
Other Safety Objectives
To evaluate the long-term (5-year) rate of therapy-related adverse events.
To evaluate the long-term (5-year) rate of device (neuroregulator or lead) malfunction requiring a revision procedure.
To specifically report events involving the lead over 5 years such as lead breakage/fracture, twisting/entanglement, replacement, lead erosion, and bowel/tissue obstruction.
Efficacy Objectives
To evaluate the mean percentage excess weight loss (%EWL) through 5 years
To evaluate the percentage of subjects achieving at least 20% EWL and 25% EWL through 5 years
To evaluate the mean percentage total body weight loss (%TBL) through 5 years
To evaluate the percentage of subjects achieving at least 5% TBL and 10% TBL through 5 years
Other Objectives
To evaluate the long-term (5-year) rate of surgical revision
To evaluate the long-term (5-year) rate of surgical removal of the device
To evaluate the long-term (5-year) rate of surgical removal of the device to undergo magnetic resonance imaging (MRI)
To evaluate change in cardiovascular and metabolic risk factors (blood pressure, lipid levels, triglycerides, blood glucose, HbA1c and waist circumference)
To evaluate change in weight related quality of life (Impact of Weight on Quality of Life Questionnaire-Lite [IWQOL-Lite]) and eating behaviors (Three Factor Eating Questionnaire [TFEQ])
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| Follow-up Visits and Length of Follow-up |
At least 5 years after receiving the active device until PAS closure.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
The post-approval study enrolled 84 patients from the premarket cohort: 55 patients were active treatment subjects from the premarket study, and 29 subjects were sham control subjects from the premarket study who were to begin to receive therapy. However, 4 out of these 29 subjects chose to withdraw from the study before beginning therapy. Thus, 80 subjects were consented and received therapy as part of this PAS study.
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| Actual Number of Sites Enrolled |
8 (6 U.S. sites)
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| Patient Follow-up Rate |
78 subjects completed year 1; 71 subjects completed year 2 and year 3; 65 subjects completed year 4; and 53 subjects completed year 5 of the study.
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| Final Safety Findings |
Final safety findings (key endpoints):
Primary Safety Objective
The device- and procedural-related serious adverse event (SAE) rate (Kaplan Meier estimate) at 5 years was 6.8% (upper 95% CI: 13.8%) As the upper bound of the 95% confidence interval (CI) is less than 25% at 5 years, the study met this primary safety endpoint.
Other Safety Objectives
Long-term (5-year) rate of therapy-related adverse events: A therapy related adverse event is defined as an adverse event related to the delivery of therapy which is the application of an electronic signal to a nerve in order to partially or completely block the propagation of naturally occurring nerve action potential. A total of 61 out of 80 subjects (76.3 %) experienced a total of 142 therapy-related adverse events.
Long-term (5-year) rate of device (neuroregulator or lead) malfunction requiring a revision procedure: In the overall PAS population, 6 out of 80 (7.5%) subjects have undergone surgical revision due to device malfunction.
Events involving the lead over 5 years such as lead breakage/fracture, twisting/entanglement, replacement, lead erosion, and bowel/tissue obstruction: 6 out of 80 (7.5%) subjects experienced seven (7) lead malfunctions which included five (5) events of impedance out of range and one (1) event of twisting/entanglement. There were zero (0) events of lead erosion, lead migration, lead breakage/fracture, or bowel/tissue obstruction.
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| Final Effect Findings |
Final effectiveness findings (key endpoints):
Efficacy Objectives
Mean percentage excess weight loss (%EWL) through 5 years: The observed %EWL was 18.3% (95% CI: 12.8%, 23.9%) for the 55 subjects remaining in the study at 5 years.
Percentage of subjects achieving at least 20% EWL and 25% EWL through 5 years: Of the 55 subjects in the study at the 5-year point, 25/55 (45.5%) achieved 20% EWL and 20/55 (36.4%) achieved 25% EWL.
Mean percentage total body weight loss (%TBL) through 5 years: The observed %TBL was 6.6% (95% CI: 4.7%, 8.6%) for the 55 subjects remaining in the study at 5 years.
Percentage of subjects achieving at least 5% TBL and 10% TBL through 5 years: Of the 55 subjects in the study at the 5-year point, 32/55 (58.2%) achieved 5% TBL and 18/55 (32.7%) achieved 10% TBL.
Other Objectives
Long-term (5-year) rate of surgical revision: 7 out of 80 (8.8%) subjects have undergone 8 surgical revisions. The Kaplan-Meier rate estimate of surgical revision at 5 years is 9.9% (95% CI: 4.8%, 19.8%).
Long-term (5-year) rate of surgical removal of the device: The Kaplan-Meier rate estimate of surgical removal rate at 5 years is 33.1% (95% CI: 23.9%, 44.7%).
Long-term (5-year) rate of surgical removal of the device to undergo magnetic resonance imaging (MRI): 3 out of 80 (3.8%) subjects had the device removed to undergo an MRI.
Change in cardiovascular and metabolic risk factors (blood pressure, lipid levels, triglycerides, blood glucose, HbA1c and waist circumference): Results show nonsignificant changes in systolic, diastolic and mean arterial blood pressures; total cholesterol and HDL; LDL and triglycerides; and FPG and HbA1c compared to baseline through 60 months. Subjects maintained reductions in waist circumference.
Change in weight related quality of life (Impact of Weight on Quality of Life Questionnaire-Lite [IWQOL-Lite]) and eating behaviors (Three Factor Eating Questionnaire [TFEQ]): Improvements in quality life from baseline were maintained through 60 months. Improvements in all three factors of the TFEQ were maintained compared to baseline through 60 months.
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| Study Strengths & Weaknesses |
Study Strength and Weaknesses:
• This was a prospective study of treated patients in the US.
• There was no concurrent comparison group, which limits interpretation of the results.
• Study enrollment was lower than anticipated. Only 53 subjects completed year 5 of the study. The subjects that remained in the study may be different than those that were lost to follow up, and therefore, the generalizability of results can be limited.
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| Recommendations for Labeling Changes |
Need labeling supplement.
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