In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Adults 18 years old and over with FI who have failed conservative therapy.
It is anticipated that at least 244 patients and as many as 293 patients may
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
The primary efficacy endpoint of this study is to demonstrate that the rate of FI
re-intervention at 36 months is less than 50%
The primary safety endpoint will be the occurrence of device-related AEs.
Secondary Safety Endpoints:
The secondary safety endpoint will be the occurrence of peri-injection
device-related infectious AEs
Clinicians will review the transrectal ultrasound images to assess the size and relative location of the Solesta implant(s). Relative anatomic stability of Solesta will be assessed by comparing anatomical positioning of the Solesta implant, as determined by transrectal ultrasound, at the time of injection to positioning at 6 and 36-months after the last Solesta treatment.
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.(15)
? 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.