NCT03381365

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: London North West Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Fistula in Ano

Interventions

Type	Name	Description
DEVICE	CuraSeal Percutaneous Intraluminal Closure System

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-12-22
• Last updated: 2020-01-18

Locations

1 site across 1 country: United Kingdom