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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100014 / PAS001 |
| Date Original Protocol Accepted |
05/27/2011
|
| Date Current Protocol Accepted |
02/26/2014
|
| Study Name |
Solesta - Long Term Study
|
| Device Name |
SOLESTA INJECTABLE GEL
|
| 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 |
Prospective, single-arm, multicenter, observational clinical study.
|
| Study Population |
Adults 18-75 years old with FI who have failed conservative therapy.
|
| Sample Size |
It is anticipated that at least 244 patients and as many as 293 patients may be
enrolled in this Solesta PAS to obtain at least 150 evaluable patients from
approximately 15-20 sites with more sites to be added if necessary to meet
accrual within the 2-3 year target
|
| Key Study Endpoints |
The primary efficacy endpoint of this study is freedom from FI
reintervention.
The primary safety endpoint will be the occurrence of device-related AEs. Secondary Endpoints:
The secondary safety endpoint will be the occurrence of peri-injection device-related infectious AEs.
The secondary performance endpoints will be: 1) the presence or absence of implants (as assessed by the clinician) and 2) determine if any local shift
has occurred at 6 and 36 months after the last Solesta treatment (as assessed
by the clinician).
Secondary Efficacy Endpoints:
¿ Fecal Incontinence Quality of Life will be assessed by the Rockwood instrument, at baseline, 6, 12, and 36 months after last Solesta treatment.
¿ Cleveland Clinic Florida Fecal Incontinence Score will be collected at baseline, 6, 12, and 36 months after last Solesta treatment.
¿ A patient global assessment of improvement (i.e., GPE-Score; 7- Point Scale) will be performed at 6, 12 and 36 months after last
Time to FI reintervention will be measured from the date of last
treatment with Solesta to the date of first FI reintervention.
|
| Follow-up Visits and Length of Follow-up |
36 months
3, 6, 12, 24 and 36 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
283 subjects enrolled
|
| Actual Number of Sites Enrolled |
18 sites enrolled
|
| Patient Follow-up Rate |
67.6%
|
| Final Safety Findings |
Overall, 72 AEs related to the injection were reported in the study: 58 during the injection interval; 8 during the peri-injection interval and 6 during
the long-term interval. There were 43 device-related AEs during the injection interval (less than or equal to 2 days post-Solesta injection); 9 during the peri-injection interval (> 2 days and greater than or equal to 2 weeks post-Solesta injection) and 6 during the long-term interval (> 2 weeks post-Solesta injection).
There was also a total of 98 SAEs reported in 51 subjects (18.0%), none of which were device or injection related.
Most of the device related events were gastrointestinal disorders that resolved quickly, and none were serious.
The results for the secondary safety endpoint only include one patient with a device/procedure related infectious AE that was mild and resolved with antibiotic treatment.
|
| Final Effect Findings |
The primary objective was reached because at 36 months, 152 (79.2%) subjects were free from FI re-intervention and 40 (20.8%) were not.
The rate of re-intervention 95% confidence interval was between 14% to 24.4% which is below 50%. Therefore, the primary effectiveness endpoint was achieved before and after sensitivity analysis considering the potential bias effect of missing values.
The results regarding performance endpoints to assess the relative anatomic stability of the device were evaluated by the presence of implants and any local shift in the implant(s).
Although technical difficulties with the ultrasound scans, in general, it was possible to notice that the device did not shift from one anatomic position to another. Additionally, the low rate of FI re-interventions (up to 24%) confirms that the device has a reasonable
performance level.
|
| Study Strengths & Weaknesses |
Sample size and power were adequate throughout the study and until the end of the follow-up.
Weaknesses: No concomitant comparator group was included; the follow-up rate was low (67%).
|
| Recommendations for Labeling Changes |
Labeling changes including the design, methods and results of the post-approval study are recommended given the importance of the postapproval
results including the effectiveness, the adverse events and FI intervention rates.
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