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|
| General |
| Study Status |
Other |
| 522 Number / Requirement Number |
PS120004 / PSS001 |
| Date Original Plan Accepted |
04/26/2013
|
| Date Current Plan Accepted |
09/27/2015
|
| Study Name |
POP AE and effectiveness rates, registry
|
| Device Name |
Ams elevate anterior & apical prolapse repair system with intepro llite
|
| Root Document Number |
K082677
K121612
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
"This is a prospective, multi-center, postmarket cohort study designed to evaluate the long-term efficacy and safety of the Elevate Anterior/Apical Prolapse Repair System compared to Native Tissue Repair in the treatment of posterior or posterior/apical vaginal prolapse in females at least 18 years of age. The study will enroll an equal number of subjects into the Elevate and native tissue repair groups. The treating surgeon together with the subject will decide which treatment the subject will receive. There are two primary (non-inferiority efficacy and non-inferiority safety) objectives in this study. Both primary objectives need to be met for this study to be considered successful. The primary superiority efficacy objective will be evaluated only if the primary non-inferiority efficacy objective is met. The secondary efficacy objective will be evaluated for non-inferiority and superiority following the same analysis methods as for the primary efficacy objective and it
will only be evaluated after the primary non-inferiority efficacy objective is met."
|
| Study Population |
Women implanted with Elevate Anterior/Apical Prolapse Repair Systems and women who underwent traditional native tissue repair (NTR).
|
| Sample Size |
494 subjects (247 patients treated with Elevate Anterior/Apical Prolapse Repair System and 247 patients treated with Native Tissue Repair) will be enrolled at up to 40 study centers
|
| Key Study Endpoints |
Primary Endpoints: 1. Primary efficacy endpoint of surgical treatment "success" or "failure"; 2. Rate of device or procedural related serious adverse events through 36 months post primary prolapse repair. Secondary Endpoints: 1. Secondary efficacy endpoint of surgical treatment "success" or "failure"; 2. Rate of repeat/revision surgery; 3. Changes in QoL captured at baseline through 36 months.
|
| Follow-up Visits and Length of Follow-up |
The length of study follow-up is 3 years. Follow-up will be conducted at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
285
|
| Actual Number of Sites Enrolled |
37
|
| Patient Followup Rate |
Follow-up Rates for transvaginal mesh (TVM) arm: All 100% subjects completed procedure, 94.7% at two months, 80.9% at 6 months, 73.8% at 12 months, and 66.7% at 18 months.
Follow-up Rates for native tissue repair (NTR) arm: All 100% subjects completed procedure, 92.2% at two months, 80.3% at 6 months, 66.7% at 12 months, and 77.8% at 18 months.
|
| Final Safety Findings |
Please note that due to the sponsor decision to cease market distribution of the device and closing business, the postmarket surveillance study was not completed. The summary safety findings presented here represent the data that have been collected up to the point when sponsor ceased operations.
There were five serious AEs with a relationship to the device or procedure in the TVM group: stress incontinence, difficulty emptying bladder, labial infection, visceral organ injury, and surgical field contamination. The most common AE reported was Difficulty Emptying Bladder (45/137 or 32.8% for the TVM group; 30/94 or 31.9% for the NTR group), while Urinary Tract Infection (UTI) was the second most reported event for both groups (18/137 or 13.1% in the TVM group, and 17/94 or 18.1% in the NTR group). There were six events of TVM exposure in five patients. These events and the other events reported are known potential adverse events described in the Indications for Use. There were no new safety concerns identified in the study.
|
| Final Effectiveness Findings |
Please note that due to the sponsor decision to cease market distribution of the device and closing business, the postmarket surveillance study was not completed. The summary effectiveness findings presented here represent the data that have been collected up to the point when sponsor ceased operations.
The composite effectiveness study endpoint was defined by anatomic success (POP-Q score), subjective success (PFDI-20 question 3), and no retreatment for POP. The composite success rate at each study visit was as follows: at 2 months post procedure, 114/123 (92.7%) TVM and 70/77 (90.9%) NTR; at 6 months, 66/76 (86.8%) TVM and 44/48 (91.7%) NTR; at 12 months, 26/30 (86.7%) TVM and 17/20 (85.0%) NTR; and at 18 months, 7/8 (87.5%) TVM and 6/7 (85.7%) NTR. Please note, statistical comparisons between groups were not performed due to early study suspension, and no definite conclusions can be made.
|
| Study Strengths and Weaknesses |
Strength: The study design included a comparison group (native tissue repair).
Weakness: Due to the sponsor closing business, the study was ended early and subject follow-up through 36-months was not completed.
|
| Recommendations for Labeling Changes |
None
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