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Status unknownNCT02456324Updated May 28, 2015

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

A Phase 2 interventional study of PICS-AF Device and Historical Controls Treated with Commercially Available Fistula Plugs in Anal Fistulas and Rectal Fistulas, sponsored by Curaseal Inc.. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Curaseal Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Anal Fistulas
  • Rectal Fistulas

Keywords

  • Fistula, Anorectal
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's planned enrollment of 30 is below the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

This is the only study on the registry with Curaseal Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Patients Treated with PICS-AF device

    Device: PICS-AF Device

  • Other
    Historical Controls

    Patients Treated with Commercially Available Fistula Plug Devices at Same Sites

    Device: Historical Controls Treated with Commercially Available Fistula Plugs

Interventions

  • DevicePICS-AF Device

    This is a specialized closure system for anorectal fistulas that is sphincter sparing

  • DeviceHistorical Controls Treated with Commercially Available Fistula Plugs

    These are patients previously treated with commercially available fistula plugs.

06

What researchers measure

Primary outcomes

  1. Fistula Closure

    Defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Confirmed by MRI.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Hosptial Universitario VIRGEN DEL ROCIO
    Sevilla, 41013, Spain
    • Fernando de la Portilla, MD · Contact
    • Fernando de la Portilla, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02456324
Lead sponsor
Curaseal Inc.
Responsible party
Sponsor
First posted
May 28, 2015
Start date
May 2015
Primary completion
May 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
May 28, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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