TIPS Microspheres for Perianal Fistula
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|ClinicalTrials.gov Identifier: NCT03707769|
Recruitment Status : Unknown
Verified October 2018 by University College, London.
Recruitment status was: Recruiting
First Posted : October 16, 2018
Last Update Posted : October 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Perianal Fistula||Device: TIPS microspheres||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas|
|Actual Study Start Date :||March 15, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Fistula treatment
Treatment of fistula with TIPS microspheres
Device: TIPS microspheres
TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707769
|Contact: Richard Day, PhDfirstname.lastname@example.org|
|University College London Hospitals||Recruiting|
|London, United Kingdom|
|Contact: Nimrita Verma|