Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2017-03-15
2025-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Fistula treatment
Treatment of fistula with TIPS microspheres
TIPS microspheres
TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.
Interventions
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TIPS microspheres
TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.
Eligibility Criteria
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Inclusion Criteria
* Cryptoglandular perianal fistula
* High and low simple trans-sphincteric fistula
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
University College, London
OTHER
Responsible Party
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Locations
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University College London Hospitals
London, , United Kingdom
Countries
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Other Identifiers
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14/0845
Identifier Type: -
Identifier Source: org_study_id
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