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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P190012 / PAS001 |
| Date Original Protocol Accepted |
10/15/2021
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| Date Current Protocol Accepted |
|
| Study Name |
Spatz3 Post-Approval Study
|
| Device Name |
Spatz3 Adjustable Balloon System
|
| Clinical Trial Number(s) |
NCT02812160
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a single-arm, multi-center, US-based new enrollment study. The objective is to obtain data regarding the safety and effectiveness of the Spatz3 Adjustable Balloon System in the post-market space. This is an all-comer study.
|
| Study Population |
Adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program
|
| Sample Size |
The sample size is based on the endpoint of deflation with migration. 467 subjects are needed to achieve
80% power with a lower one-sided Z test assuming a Ho rate of 1%, observed rate of 0.03%, and
alpha=0.025. Assuming a lost-to-follow-up rate of 15%, 537 subjects will need to be enrolled.
|
| Key Study Endpoints |
The primary study endpoint is to demonstrate that the rate of device or procedure related SAEs is less than 8% at 8 months.
The secondary study endpoint is to demonstrate that the mean percent TBL in the effectiveness cohort is not less than 14% at eight months.
Other study endpoints (through 32 weeks) include:
• weight loss measured by percent excess weight
loss (%EWL)
• device- and/or procedure-related adverse
events with respect to severity, relationship to
the device and/or procedure, and rate of
occurrence
• Rates for the following events:
o gastric ulcers,
o esophageal injury,
o spontaneous hyperinflation*,
o microorganism growth (inside and
outside of the balloon)*,
o acute pancreatitis,
o aspiration,
o esophageal perforation,
o gastric perforation,
o bowel perforation,
o death,
o early explants,
o deflations,
o deflations with migrations, and
o deflations that are vomited
*Culturing data will be collected for balloon that spontaneously hyperinflate or have microorganism growth inside and/or outside of the balloon
Weight maintenance measured by percent excess weight loss (%EWL) and %TBL at 6 months post-explantation will be assessed on an effectiveness
cohort - patients who achieved at least 5% TBL at the end of the 8 month treatment period.
|
| Follow-up Visits and Length of Follow-up |
8 months or 14 months for patients who achieve at least 5% TBL by the end of the 8 month treatment period
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
539
|
| Actual Number of Sites Enrolled |
23
|
| Patient Follow-up Rate |
Follow-up Rate Of the 539, 417 (77.3%) completed the study at week 32 as planned, 76 (14%) had an early balloon removal due to AE and 28 (5.2%) had an early balloon removal due to other causes such as withdraw consent, relocation or reaching goal weight. 18 subjects (3.4%) were lost to follow up before week 52. 2 (0.4%) were unreachable after implantation and 16 subjects (3.0%) had incomplete study data due to site’s (13 and 14) lack of communication and monitoring.
Out of 417 subjects completed week 32, 59 (10.9%) did not reach 5 TBL% therefore did not continue to follow up. Out of the 358 (66.4%) who continued to follow up, 151 (42%) completed all 24-week follow-up period.
207 subjects (38.4%) were lost to follow-up after week 32, These subjects had undergone device removal as scheduled and subsequently became non-responsive to follow-up attempts. Because this occurred after device removal, absence of the follow up visits does not impact on the safety or efficacy analysis up to week 32.
|
| Final Safety Findings |
Adverse Events (AEs) related to Spatz3 balloon treatment occurred in 17.1% of subjects. Serious AEs (SAEs) occurred in 17 (3.1%) of subjects. Overall, 69.4% of subjects experienced balloon-related AEs; 17.1% experienced severe AEs, and 2.2% experienced SAEs. The most frequent AEs were symptoms of intolerance, including nausea (49.7%), vomiting (39.5%), dyspepsia (36.9%), and abdominal discomfort (35.8%). No deaths occurred in the study. Four hyperinflation events (0.7%) were reported in the study and they occurred several months after implantation.
|
| Final Effect Findings |
The mean %TBL for ITT population (n=539) was 13.2% at 32 weeks. Therefore, the study met the pre-specified endpoint of 11%. Across the 23 sites, the %TBL range from 9.2% to 17.4%.The response rate (defined as %TBL greater than or equal to 5%) was more than the 50% goal (TBL greater than or equal to 5% = 97.5% LCB = 80.0%), the observed rate of subjects who maintained 40% of the weight loss with the balloon at six months exceeded the 50% performance goal (Maintained greater than or equal to 40% weight loss = 89.3%), and the response rate (defined as EWL greater than or equal to 25%) exceeded (EWL greater than or equal to 25% = 76.4%).
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| Study Strengths & Weaknesses |
Strength: All “comers study” allows for better reflection of real-world clinical practice and results are more generalizable. Weakness: high number of deviations (missed visits/assessments)
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| Recommendations for Labeling Changes |
None
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