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

Primary Purpose

Anal Fistulas, Rectal Fistulas

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

PICS-AF Device

Historical Controls Treated with Commercially Available Fistula Plugs

About this trial

This is an interventional treatment trial for Anal Fistulas focused on measuring Fistula, Anorectal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Subject is known to be a carrier for drug-resistant bacteria.

Sites / Locations

Hosptial Universitario VIRGEN DEL ROCIORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment Group

Historical Controls

Arm Description

Patients Treated with PICS-AF device

Patients Treated with Commercially Available Fistula Plug Devices at Same Sites

Outcomes

Primary Outcome Measures

Fistula Closure

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02456324

First Posted

May 26, 2015

Last Updated

May 26, 2015

Sponsor

Curaseal Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02456324

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Curaseal Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fistulas, Rectal Fistulas

Keywords

Fistula, Anorectal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Patients Treated with PICS-AF device

Arm Title

Historical Controls

Arm Type

Other

Arm Description

Patients Treated with Commercially Available Fistula Plug Devices at Same Sites

Intervention Type

Device

Intervention Name(s)

PICS-AF Device

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Historical Controls Treated with Commercially Available Fistula Plugs

Intervention Description

These are patients previously treated with commercially available fistula plugs.

Primary Outcome Measure Information:

Title

Fistula Closure

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Subject is known to be a carrier for drug-resistant bacteria.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kenton D Fong, MD

Phone

650-799-6298

kfong@curaseal.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jaap Delange

Phone

+31 416 36 50 77

jdelange@optis.nl

Facility Information:

Facility Name

Hosptial Universitario VIRGEN DEL ROCIO

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando de la Portilla, MD

First Name & Middle Initial & Last Name & Degree

Fernando de la Portilla, MD

12. IPD Sharing Statement

Learn more about this trial

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

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