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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Solesta - Long Term Study

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Study Status Completed
Application Number P100014 / PAS001
Date Current Protocol Accepted 02/26/2014
Study Name Solesta - Long Term Study
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 Design Description Prospective, single-arm, multicenter, observational clinical study.
Study Population Description 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

Data Collection The primary efficacy endpoint of this study is freedom from FI


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.

Solesta - Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
case report forms 10/27/2011 10/27/2011 On Time
six month report 11/25/2011 12/16/2011 Overdue/Received
one year report 05/26/2012 06/13/2012 Overdue/Received
18 month report 11/24/2012 01/22/2013 Overdue/Received
two year report 05/26/2013 06/19/2013 Overdue/Received
three year report 07/10/2014 07/10/2014 On Time
four year report 05/26/2015 12/15/2015 Overdue/Received
five year report 07/29/2016 08/01/2016 Overdue/Received
six year report 11/30/2017 11/22/2017 On Time
seven year report 09/28/2018 09/26/2018 On Time
Final Report 12/01/2019 12/23/2019 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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