Hemorrhoidal DiseaseEMBORRHOIDNCT02303925
Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease
A study testing NESTER COILS in people with Hemorrhoidal Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoidal Disease
- What is being tested?
- NESTER COILS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2014to 30 Jun 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from a symptomatic hemorrhoidal disease stage II or III (history of prior medical treatment or instrumental do not prohibit the inclusion in the study)
- Patient agreeing to participate in the study and who signed an informed consent
- Patient willing to lend to post-operative monitoring for a year
- Patient assured social
Who cannot join
- Diseases and colorectal proctologic / History proctologic
- Acute Complication hemorrhoidal disease course (thrombosis)
- History of proctology surgery for hemorrhoidal disease
- Anal stenosis congenital or acquired
- Chronic anal fissure, anal suppuration associated
- Chronic Inflammatory Bowel Disease
Show all 20Show fewer
- History of colorectal cancer
- History of rectal resection and / or sigmoid
- Rectal prolapse
- Comorbidities
- Portal hypertension
- Severe atherosclerotic pathology (significant stenosis in aorto-iliac-femoral artery or branches for visceral).
- General Affection responsible for a disorder of hemostasis objective (hemophilia, von Willebrand disease thrombocytopenia) and anticoagulants.
- Psychiatric disorder making it impossible informed of and / or postoperative care
- Neurological disease directly or indirectly involving the rectosphinctérienne motor (multiple sclerosis, spinal cord injury or nerve root, polyneuropathy).
- Patients whose condition appears too insecure or taking steroids or immunosuppressive leading to an unacceptable surgical risk.
- Background
- Pregnancy declared (the existence of effective contraception will be checked for women of childbearing age)
- Major Trust
- Patients who do not speak French, refusing or unfit for monitoring proposed in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, Marseille, 13005
About this study
With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute complications (external and/or internal thromboses) are unpredictable.
Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal surgery. This technique consists in a ligation of the superior rectal artery under Doppler control in order to decrease the blood flow within the hemorrhoids and therefore to reduce them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).
Read more
With the major advances in interventional radiology such ligation could be performed by an endovascular coil embolization. Until now no direct study exists on the subject but several case reports show the feasibility of an embolization of the superior rectal arteries for rectorrhagia of various etiologies such as the hemorrhoidal disease.
Endovascular access should increase the selectivity of the embolization compared to the Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches of the superior rectal artery and therefore to occlude permanently the branches that feed the hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main complications of the trans-anal access technique.
The primary objective of this study is : the assessment of the efficacy of endovascular coil embolization of the superior rectal arteries in the management of the symptoms of the hemorrhoidal disease grade II and III. The secondary objective is : the assessment of postoperative complications.
- Conditions
- Hemorrhoidal Disease
- Being tested
- NESTER COILS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NESTER COILSDevice
| Study group | Role | What they receive |
|---|---|---|
| coils | Experimental | Not described Receives: Device: NESTER COILS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the felt pain
It will be expected a decrease of the felt pain at least of 2 points measured by visual analog scale for patients treated by coil embolization
Measured: 26 MONTHS
Secondary outcomes (1)
Reaaparition or obstinacy of the hemorroidal symptoms
Reaaparition or obstinacy of the symptoms will be assess by clinical exam at 1,3,6 and 12 months
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start14 Dec 2014
- Primary completionApr 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhoidal DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hopitaux De Marseillevincent vidal, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303925
- Sponsor's protocol ID
- 2013-41
- Acronym
- EMBORRHOID
- Status last verified
- Aug 2016
- First submitted
- 19 Nov 2014
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.
PubMed 29724519
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Superior Rectal Artery Embolization for the Treatment of Hemorrhoidal Disease
- ClinicalTrials.gov ID
- NCT02303925
- Acronym / sponsor ID
- EMBORRHOID / 2013-41
- Conditions
- Hemorrhoidal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Dec 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Dec 2014 (estimated)
- 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.
With an estimated prevalence between 4 and 35%, the hemorrhoidal disease is the most frequent proctologic disease. Its symptoms are mainly rectorrhagia, externalization of the hemorrhoidal cushions (muco-hemorrhoidal prolapse), and/or pain and pruritus. Its acute complications (external and/or internal thromboses) are unpredictable.
Surgical treatment concerns approximately 10% of patients with diagnosed hemorrhoidal pathologies. The elective ligature of the arteria haemorrhoidalis under trans-anal Doppler scanning was developed in order to reduce the postoperative morbidity of hemorrhoidal surgery. This technique consists in a ligation of the superior rectal artery under Doppler control in order to decrease the blood flow within the hemorrhoids and therefore to reduce them. It is effective in the treatment of internal hemorrhoidal pathology without prolapse (grade II). The complications rate is low and estimated between 2 and 12% : rectorrhagia (4.3%), thrombosed hemorrhoids (1,8%), fissure (0,8%), acute urine retention (0,7%).
With the major advances in interventional radiology such ligation could be performed by an endovascular coil embolization. Until now no direct study exists on the subject but several case reports show the feasibility of an embolization of the superior rectal arteries for rectorrhagia of various etiologies such as the hemorrhoidal disease.
Endovascular access should increase the selectivity of the embolization compared to the Doppler scanning technique. Indeed the arteriography makes it possible to scan all branches of the superior rectal artery and therefore to occlude permanently the branches that feed the hemorrhoidal plexuses. Moreover the endovascular embolization technique should avoid the main complications of the trans-anal access technique.
The primary objective of this study is : the assessment of the efficacy of endovascular coil embolization of the superior rectal arteries in the management of the symptoms of the hemorrhoidal disease grade II and III. The secondary objective is : the assessment of postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coils | Experimental | Device: NESTER COILS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffering from a symptomatic hemorrhoidal disease stage II or III (history of prior medical treatment or instrumental do not prohibit the inclusion in the study)
- Patient agreeing to participate in the study and who signed an informed consent
- Patient willing to lend to post-operative monitoring for a year
- Patient assured social
Key exclusion criteria (20 listed)
- Diseases and colorectal proctologic / History proctologic
- Acute Complication hemorrhoidal disease course (thrombosis)
- History of proctology surgery for hemorrhoidal disease
- Anal stenosis congenital or acquired
- Chronic anal fissure, anal suppuration associated
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 |
|---|---|---|
| NESTER COILS | Device | coils |
Primary outcome
Decrease of the felt pain
Time frame: 26 MONTHS
It will be expected a decrease of the felt pain at least of 2 points measured by visual analog scale for patients treated by coil embolization
1 secondary outcome
Reaaparition or obstinacy of the hemorroidal symptoms
Time frame: 26 months
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 8 May 2026.
- Results publication: PubMed 29724519Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.
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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.
Urielle DESALBRES study director
Assistance Publique Hopitaux De Marseille
vincent vidal principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NESTER COILS in people with Hemorrhoidal Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 20 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 8 May 2026. 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 France. 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?
Decrease of the felt pain (time frame: 26 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303925, which also lists 1 linked publication.
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 8 May 2026.