Investigating a novel device as a treatment for fistula-in-ano

A clinical investigation of a novel Seton Device to treat fistula-in-ano

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12013338

Enrollment

Registered

2021-04-06

Start date

2021-03-20

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical procedure to treat fistula in ano (anal fistula) Digestive System Anal fistula

Interventions

This prospective cohort study will run for a total of 1-year duration. We aim to recruit in 6 months, with a follow-up of each patient for 3 months and 3 months for buffer, analysis and write-up. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Requires treatment for a fistula in ano 2. Patients over 18 years old 3. Patients with FIA resulting from cryptoglandular pathology

Exclusion criteria

Exclusion criteria: 1. Patients with proven inflammatory bowel disease 2. Patients who are unable to give consent 3. Patients with known allergies to PLLA or Polysorb sutures 4. Patients who are pregnant, attempting to conceive or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. Safety –continuous monitoring of any adverse events and review compared to standard treatment at study end 2. Performance – clinical examination of fistula wound at 12 weeks 3. Usability – diary and pain and comfort questionnaire at weeks 1, 2, 3, 4, 6, 8, 12 4. Patient acceptability –diary and pain and comfort questionnaire at weeks 1, 2, 3, 4, 6, 8, 12 5. Clinician acceptability – questionnaire completed post-implant surgery	—

Measure

Time frame

1. Safety –continuous monitoring of any adverse events and review compared to standard treatment at study end 2. Performance – clinical examination of fistula wound at 12 weeks 3. Usability – diary and pain and comfort questionnaire at weeks 1, 2, 3, 4, 6, 8, 12 4. Patient acceptability –diary and pain and comfort questionnaire at weeks 1, 2, 3, 4, 6, 8, 12 5. Clinician acceptability – questionnaire completed post-implant surgery

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026