HemorrhoidsNCT06175325
Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids
A study testing Trans-radial embolisation of haemorrhoids in people with Hemorrhoids, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Trans-radial embolisation of haemorrhoids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients eligible for the study must comply with all of the following prior to enrolment:
- Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
- Patients with (i) who do not wish to undergo surgery for their symptoms
- Patients with (i) despite recent surgery
- Patients willing and able to give fully informed consent
- Patients aged ≥18 years
Who cannot join
- Patients who are not otherwise fit for surgery
- Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
- Patient who are unable to sign the informed consent form.
- Patients who are pregnant (completed as part of standard IRMER protocol)
- Patients with history of significant colorectal disease or previous colectomy.
- Patients with history of an allergic reaction to x-ray contrast
- Patients who are currently involved in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
Aviva Ogbolosingha, 01782675380, aviva.ogbolosingha@uhnm.nhs.uk
AbdelKader Allouni
About this study
Official title: Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids
Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.
- Conditions
- Hemorrhoids
- Being tested
- Trans-radial embolisation of haemorrhoids
- Keywords
- Embolisation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-radial embolisation of haemorrhoidsProcedure or surgery
Once patients have provided informed consent to participate, an assessment of symptom severity will be obtained during the initial visit using the a standardised set of 4 validated scoring systems used in research of haemorrhoidal disease. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS). Routine blood tests will be taken. During the procedure, routine observations will be recorded on the paper CRF. The data collected on the paper CRF will be entered onto the electronic CRF.
The Transarterial fluoroscopically guided superior rectal artery embolization procedure will be performed on all participants. It is a day case procedure performed under local anaesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Trans-radial embolisation of haemorrhoids | Other | Haemorrhoids will be treated using arterial embolisation, using a trans-radial approach Receives: Procedure: Trans-radial embolisation of haemorrhoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and long-term effects
Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications
Measured: 3 years
Secondary outcomes (7)
Change of symptoms
Improvement in haemorrhoid related symptoms at 3 months using a questionnaire consisting of 4 standardised scoring systems. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS).
Measured: 3 months
Change of symptoms
Improvement in haemorrhoid related symptoms at 12 months using a questionnaire consisting of 4 standardised scoring systems. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS).
Measured: 12 months
Change of symptoms
Improvement in haemorrhoid related symptoms at 24 months using a questionnaire consisting of 4 standardised scoring systems. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS).
Measured: 24 months
Cost comparison
Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation
Measured: 3 years
Procedural times comparison
Comparison with other similar studies using trans-femoral approach regarding procedural times
Measured: 3 years
Radiation dose comparison
Comparison with other similar studies using trans-femoral approach regarding radiation dose
Measured: 3 years
Contrast volume comparison
Comparison with other similar studies using trans-femoral approach regarding contrast volume
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start17 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175325
- Sponsor's protocol ID
- 2602
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids
- ClinicalTrials.gov ID
- NCT06175325
- Acronym / sponsor ID
- 2602
- Conditions
- Hemorrhoids
- Keywords
- Embolisation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2023 (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.
Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-radial embolisation of haemorrhoids | Other | Procedure: Trans-radial embolisation of haemorrhoidsHaemorrhoids will be treated using arterial embolisation, using a trans-radial approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
- Patients with (i) who do not wish to undergo surgery for their symptoms
- Patients with (i) despite recent surgery
- Patients willing and able to give fully informed consent
- Patients aged ≥18 years
Key exclusion criteria (7 listed)
- Patients who are not otherwise fit for surgery
- Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
- Patient who are unable to sign the informed consent form.
- Patients who are pregnant (completed as part of standard IRMER protocol)
- Patients with history of significant colorectal disease or previous colectomy.
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 |
|---|---|---|
| Trans-radial embolisation of haemorrhoidsOnce patients have provided informed consent to participate, an assessment of symptom severity will be obtained during the initial visit using the a standardised set of 4 validated scoring systems used in research of haemorrhoidal disease. These include the French bleeding score (FBS), Goligher classification of internal haemorrhoids (GS), quality of life score (QoL) and Visual analogue score for pain (VAS). Routine blood tests will be taken. During the procedure, routine observations will be recorded on the paper CRF. The data collected on the paper CRF will be entered onto the electronic CRF. The Transarterial fluoroscopically guided superior rectal artery embolization procedure will be performed on all participants. It is a day case procedure performed under local anaesthetic. | Procedure or surgery | Trans-radial embolisation of haemorrhoids |
Primary outcome
Safety and long-term effects
Time frame: 3 years
Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications
7 secondary outcomes
Change of symptoms
Time frame: 3 months
Change of symptoms
Time frame: 12 months
Change of symptoms
Time frame: 24 months
Cost comparison
Time frame: 3 years
Procedural times comparison
Time frame: 3 years
Radiation dose comparison
Time frame: 3 years
Contrast volume comparison
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 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.
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-radial embolisation of haemorrhoids in people with Hemorrhoids, run by University Hospitals of North Midlands NHS Trust 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 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and long-term effects (time frame: 3 years). 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 3 Sep 2025.