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

May 26, 2015 updated by: Curaseal Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41013
        • Recruiting
        • Hosptial Universitario VIRGEN DEL ROCIO
        • Contact:
          • Fernando de la Portilla, MD
        • Principal Investigator:
          • Fernando de la Portilla, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
  2. Subject must be at least 18 years of age and no older than 75 years of age.
  3. Subject has been diagnosed with a single internal opening anorectal fistula (not multiple internal openings) that is clinically indicated for treatment.
  4. Subject must have a fistula tract that is > 2.0 cm in length based on measurements from imaging studies or upon probing of the fistula tract.
  5. Subject should have a clean and infection-free fistula tract that has been properly drained.
  6. Subject must be able to comply with study and study follow-up requirements.

Exclusion Criteria:

  1. Subject with a life expectancy < 6 months.
  2. Subject with anorectal fistula due to Crohn's disease or malignancy.
  3. Subject is severely malnourished.
  4. Subject with a history of sensitivity or allergy to bovine materials.
  5. Subject is on active chemotherapy treatment that may interfere with wound healing.
  6. Subject has an active infection (cellulitis) or an undrained abscess in fistula tract.
  7. Subject has a horseshoe fistula tract.
  8. Subject has a history of radiation therapy to anus or rectum.
  9. Subject is affected by uncontrolled diabetes.
  10. Subjects with subcutaneous, ano-vaginal, or pouch-vaginal fistula.
  11. Subject presents with end stage renal disease requiring dialysis.
  12. Subject is pregnant or planning to become pregnant (verbal report).
  13. Subject is unable or unwilling to provide informed consent.
  14. Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
  15. Subject has an American Society of Anesthesia PS classification of greater than 3.
  16. Subject is known to be a carrier for drug-resistant bacteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Historical Controls
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Curaseal Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP0777

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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