NCT02456324

A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Curaseal Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anal Fistulas
• Rectal Fistulas

Interventions

Type	Name	Description
DEVICE	PICS-AF Device	This is a specialized closure system for anorectal fistulas that is sphincter sparing
DEVICE	Historical Controls Treated with Commercially Available Fistula Plugs	These are patients previously treated with commercially available fistula plugs.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2015-05-28
• Last updated: 2015-05-28

Locations

1 site across 1 country: Spain