A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
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|ClinicalTrials.gov Identifier: NCT02456324|
Recruitment Status : Unknown
Verified May 2015 by Curaseal Inc..
Recruitment status was: Recruiting
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anal Fistulas Rectal Fistulas||Device: PICS-AF Device Device: Historical Controls Treated with Commercially Available Fistula Plugs||Phase 2|
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.
- Fistula closure at 3 months post-procedure as determined by physical examination.
- The cessation of egress of enteric fluid from the fistula tract or stable complete closure of the mucosal internal fistula opening by physical examination.
- Safety post-procedure through 3-month follow-up period.
- Infection (e.g., systemic or abscess).
- Time to fistula closure.
- Need for repeat procedure or other required surgical intervention.
- Incontinence levels before and after treatment.
- Quality of life assessments before and after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: Treatment Group
Patients Treated with PICS-AF device
Device: PICS-AF Device
This is a specialized closure system for anorectal fistulas that is sphincter sparing
Patients Treated with Commercially Available Fistula Plug Devices at Same Sites
Device: Historical Controls Treated with Commercially Available Fistula Plugs
These are patients previously treated with commercially available fistula plugs.
- Fistula Closure [ Time Frame: 6 months ]Defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Confirmed by MRI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456324
|Contact: Kenton D Fong, MDfirstname.lastname@example.org|
|Contact: Jaap Delange||+31 416 36 50 email@example.com|
|Hosptial Universitario VIRGEN DEL ROCIO||Recruiting|
|Sevilla, Spain, 41013|
|Contact: Fernando de la Portilla, MD|
|Principal Investigator: Fernando de la Portilla, MD|