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RecruitingNCT06175325Updated Sep 3, 2025

Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids

An interventional study of Trans-radial embolisation of haemorrhoids in Hemorrhoids, sponsored by University Hospitals of North Midlands NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by University Hospitals of North Midlands NHS Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Hemorrhoids

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Keywords

  • Embolisation
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

University Hospitals of North Midlands NHS Trust is the lead sponsor of 28 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • Patients aged ≥18 years

Exclusion criteria

Exclusion Criteria:

  • Patients who are not otherwise fit for surgery
  • Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
  • Patient who are unable to sign the 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Trans-radial embolisation of haemorrhoids

    Haemorrhoids will be treated using arterial embolisation, using a trans-radial approach

    Procedure: Trans-radial embolisation of haemorrhoids

Interventions

  • ProcedureTrans-radial embolisation of haemorrhoids

    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.

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What researchers measure

Primary outcomes

  1. Safety and long-term effects

    Safety and efficacy of the haemorrhoid embolisation procedure in relation to the rate of immediate and long-term complications

    Time frame: 3 years

Secondary outcomes

  1. 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).

    Time frame: 3 months

  2. 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).

    Time frame: 12 months

  3. 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).

    Time frame: 24 months

  4. Cost comparison

    Comparison of the cost (in pounds £) associated with arterial embolisation, using a trans-radial approach to a traditional surgical operation

    Time frame: 3 years

  5. Procedural times comparison

    Comparison with other similar studies using trans-femoral approach regarding procedural times

    Time frame: 3 years

  6. Radiation dose comparison

    Comparison with other similar studies using trans-femoral approach regarding radiation dose

    Time frame: 3 years

  7. Contrast volume comparison

    Comparison with other similar studies using trans-femoral approach regarding contrast volume

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175325
Lead sponsor
University Hospitals of North Midlands NHS Trust
Responsible party
Sponsor
First posted
Dec 18, 2023
Start date
Jul 17, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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