NCT02456324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 26, 2015

Last Update Submit

May 26, 2015

Conditions

Anal FistulasRectal Fistulas

Keywords

Fistula, Anorectal

Outcome Measures

Primary Outcomes (1)

  • Fistula Closure

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

    6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Patients Treated with PICS-AF device

Device: PICS-AF Device

Historical Controls

OTHER

Patients Treated with Commercially Available Fistula Plug Devices at Same Sites

Device: Historical Controls Treated with Commercially Available Fistula Plugs

Interventions

PICS-AF DeviceDEVICE

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

Treatment Group
Historical Controls Treated with Commercially Available Fistula PlugsDEVICE

These are patients previously treated with commercially available fistula plugs.

Historical Controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
  • Subject must be at least 18 years of age and no older than 75 years of age.
  • Subject has been diagnosed with a single internal opening anorectal fistula (not multiple internal openings) that is clinically indicated for treatment.
  • 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.
  • Subject should have a clean and infection-free fistula tract that has been properly drained.
  • Subject must be able to comply with study and study follow-up requirements.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hosptial Universitario VIRGEN DEL ROCIO

Seville, Sevilla, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Kenton D Fong, MD

CONTACT

650-799-6298kfong@curaseal.com

Jaap Delange

CONTACT

+31 416 36 50 77jdelange@optis.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

ES(1)