- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707769
TIPS Microspheres for Perianal Fistula
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Richard Day, PhD
- Phone Number: +442031082183
- Email: r.m.day@ucl.ac.uk
Study Locations
-
-
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London, United Kingdom
- Recruiting
- University College London Hospitals
-
Contact:
- Nimrita Verma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/0845
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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