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TIPS Microspheres for Perianal Fistula

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
University College, London

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Richard Day, PhD +442031082183 r.m.day@ucl.ac.uk

Locations
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United Kingdom
University College London Hospitals Recruiting
London, United Kingdom
Contact: Nimrita Verma         
Sponsors and Collaborators
University College, London
University College London Hospitals
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03707769    
Other Study ID Numbers: 14/0845
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases