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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Curaseal Inc.

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Kenton D Fong, MD 650-799-6298 kfong@curaseal.com
Contact: Jaap Delange +31 416 36 50 77 jdelange@optis.nl

Locations
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Spain
Hosptial Universitario VIRGEN DEL ROCIO Recruiting
Sevilla, Spain, 41013
Contact: Fernando de la Portilla, MD         
Principal Investigator: Fernando de la Portilla, MD         
Sponsors and Collaborators
Curaseal Inc.
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Responsible Party: Curaseal Inc.
ClinicalTrials.gov Identifier: NCT02456324    
Other Study ID Numbers: TP0777
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Curaseal Inc.:
Fistula, Anorectal
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases