NCT03381365

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 18, 2020

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

December 18, 2017

Last Update Submit

January 15, 2020

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (1)

  • fistula healing

    clinical and radiological healing

    1 year

Secondary Outcomes (1)

  • adverse effects or perioperative compilations related to device

    within first year

Study Arms (1)

investigational arm

EXPERIMENTAL
Device: CuraSeal Percutaneous Intraluminal Closure System

Interventions

CuraSeal Percutaneous Intraluminal Closure SystemDEVICE
investigational arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London North West Healthcare NHS Trust

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 22, 2017

Study Start

September 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 18, 2020

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)