TIPS Microspheres for Perianal Fistula

November 10, 2020 updated by: University College, London

First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas

Phase of Investigation: First-in-human feasibility study

Objectives: Primary objective: Demonstration that TIPS microspheres do not compromise the clinical condition or safety of the patient.

Secondary objective: To demonstrate that TIPS microspheres facilitate natural healing in the context of perianal fistula.

Type of Investigation: First-in-human single site, open label, feasibility study to assess the safety of TIPS microspheres in perianal fistulas and indicative functionality.

Investigation design and methods: First-in-human single delivery of a bioabsorbable device to treat perianal fistula. A standard of care internal flap procedure performed to close the internal fistula opening and up to 300 mg of TIPS microspheres will be inserted into each perianal fistula. Participants will be assessed for healing, inflammation, abscess, sepsis, pain and continence by clinical assessments, blood tests, MRI and questionnaires.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

TIPS microspheres are manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) under Good Laboratory Practice (GLP) conditions.

Microspheres will be delivered into the fistula tract using the following procedure:

i) Tract identification with special emphasis on locating the internal and external openings using a fistula probe.

ii) Curettage to remove epithelium lining the tract and cleaning by irrigation with hydrogen peroxide and saline.

iii) Closure of the internal opening by means of a rectoanal advancement flap. iv) Following device kit instructions, prepare a paste of TIPS microspheres with GranuGel.

v) Introduction of TIPS microsphere paste by back-filling. vi) Retention of the microsphere paste using Comfeel adhesive hydrocolloid dressing designed to remain in place for 1 - 14 days.

Each subject will receive a single administration of up to 300 mg of TIPS microspheres implanted into the fistula tract.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • London, United Kingdom
        • Recruiting
        • University College London Hospitals
        • Contact:
          • Nimrita Verma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years and above
  • Cryptoglandular perianal fistula
  • High and low simple trans-sphincteric fistula

Exclusion Criteria:

  • Secondary fistula, including Crohn's disease, carcinoma, radiotherapy, tuberculosis
  • Evidence of branching fistula anatomy or cavity on MRI
  • Inter-sphincteric fistula
  • Low trans-phincterictrans-sphincteric fistula amenable to simple fistulotomy
  • Immunosuppressed patients
  • Participants less than 18 years of age
  • Unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fistula treatment
Treatment of fistula with TIPS microspheres
TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Within 9 months of device implantation
Safety as defined by morbidity, measured by occurrence of adverse events / reactions, in particular: perianal sepsis, perianal abscess, or reoperation due to sepsis
Within 9 months of device implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evidence of fistula healing
Time Frame: 9 months after device implantation
Efficacy through facilitation of natural healing as determined by: clinical evidence of fistula healing; MRI evidence of fistula healing; improvement of quality of life assessment Improvement of pain score assessment
9 months after device implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2017

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

April 30, 2022

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (ACTUAL)

October 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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