Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula

A Pilot Study to Assess the Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening (Curaseal AF) as a Treatment for Perianal Fistula

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging.

Study Overview

• Status: Terminated
• Conditions: Fistula in Ano
• Intervention / Treatment: Device: CuraSeal Percutaneous Intraluminal Closure System

Detailed Description

Perianal fistula is a challenging condition for colorectal surgeons. Achieving a favourable balance between healing and incontinence is the key to success. Surgeons have adopted many methods to close off this abnormal tract, which include laying opening, use of setons, advancement flaps and permanent stoma. A more recent approach has been the use of devices or substances to block the tract in the hope that it will seal off. Most of the devices that have been used to close the tract have not proved to be as effective in healing as a lay open with high rates of fistula persistence. A major failure of the devices has been their early expulsion and their inability to seal off the internal opening.

The new Curaseal plug may be able to overcome these shortcomings. This plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure.

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, HA1 3UJ
    • London North West Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are psychologically stable and suitable for intervention and able to provide informed consent

  • Patients who are willing and competent to fill in questionnaires and undergo investigations at various time points during the study
  • Patients with an idiopathic extra and trans-sphincteric perianal fistula.

Exclusion Criteria:

• Patients aged less than 18 or >80 years.
• Patients unfit to undergo general or spinal anaesthesia.
• Patients with a supra-levator fistula.
• Patients with a rectovaginal fistula.
• Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
• Patients with a fistula secondary to trauma, foreign body, developmental cyst or pelvic irradiation.
• Patients who are immunosuppressed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: investigational arm	Device: CuraSeal Percutaneous Intraluminal Closure System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fistula healing	clinical and radiological healing	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse effects or perioperative compilations related to device	within first year

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: 195923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No