Perianal FistulaNCT03707769
TIPS Microspheres for Perianal Fistula
A study testing TIPS microspheres in people with Perianal Fistula, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- TIPS microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2017to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- Cryptoglandular perianal fistula
- High and low simple trans-sphincteric fistula
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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:
- 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.
- 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
- Perianal Fistula
- Being tested
- TIPS microspheres
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS microspheresDevice
TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.
| Study group | Role | What they receive |
|---|---|---|
| Fistula treatment | Experimental | Treatment of fistula with TIPS microspheres Receives: Device: TIPS microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety as defined by morbidity, measured by occurrence of adverse events / reactions, in particular: perianal sepsis, perianal abscess, or reoperation due to sepsis
Measured: Within 9 months of device implantation
Secondary outcomes (1)
Clinical evidence of fistula healing
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
Measured: 9 months after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start15 Mar 2017
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707769
- Sponsor's protocol ID
- 14/0845
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2018
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Open Label Feasibility Study to Assess the Safety of TIPS Microspheres in Perianal Fistulas
- ClinicalTrials.gov ID
- NCT03707769
- Acronym / sponsor ID
- 14/0845
- Conditions
- Perianal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fistula treatment | Experimental | Device: TIPS microspheresTreatment of fistula with TIPS microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and above
- Cryptoglandular perianal fistula
- High and low simple trans-sphincteric fistula
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPS microspheresTIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel. | Device | Fistula treatment |
Primary outcome
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
1 secondary outcome
Clinical evidence of fistula healing
Time frame: 9 months after device implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS microspheres in people with Perianal Fistula, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Within 9 months of device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.