Anal Fistulas Clinical Trial
Official title:
A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal fistulas.
The primary objective of this post-market study is to generate clinical data to evaluate the
performance and safety of the PICS AF devices for the treatment of anorectal fistulas and to
compare success rates of fistula closure to historical controls of commercially available
devices for anorectal fistula repair performed at the participating clinical sites. Data
will be obtained from this study to support the safety and effectiveness of the PICS AF
device for promoting fistula closure and healing.
PRIMARY EFFECTIVENESS ENDPOINT:
Fistula closure success at 6 months is defined as complete healing of the fistula tract and
associated external opening without drainage or abscess. Fistula closure success for the
PICS-AF device will be assessed at the 6 month follow up visit using MRI. The rate of the
PICS-AF closure success at 6 months will compared to the closure rate obtained from
historical controls that were followed for similar time periods.
PRIMARY SAFETY ENDPOINT:
The proportion of subjects experiencing a serious adverse event (i.e., an infection,
enlargement of the fistula, an allergic reaction to the PICS-AF device, etc.) through 6
months of post-procedure follow-up.
SECONDARY ENDPOINTS:
1. Fistula closure at 3 months post-procedure as determined by physical examination.
2. The cessation of egress of enteric fluid from the fistula tract or stable complete
closure of the mucosal internal fistula opening by physical examination.
3. Safety post-procedure through 3-month follow-up period.
4. Infection (e.g., systemic or abscess).
5. Time to fistula closure.
6. Need for repeat procedure or other required surgical intervention.
7. Incontinence levels before and after treatment.
8. Quality of life assessments before and after treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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