HemorrhoidsRF-GREPNCT04229784
Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
A study testing Radiofrewuency surgery in people with Hemorrhoids and Surgical Procedure, Unspecified, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids, Surgical Procedure, Unspecified
- What is being tested?
- Radiofrewuency surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Jul 2021
- 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
- Male and female consultant for a grade II or III haemorrhoidal pathology after failure of medical-instrumental treatments.
- Age > 18 years old and < 75 years old
- Patient having signed an informed consent
- Affiliate or beneficiary of a social security scheme
- For patients taking anti-vitamin K (AVK) or oral anticoagulants (OACs) a short stop will be recommended according to HAS recommendations.
- For patients on antiplatelet agents (APA), the relay and stopping procedures will be carried out according to the current recommendations of the HAS (26)
- Patient eligible to be an outpatient
Who cannot join
- Patient with IBD (inflammatory bowel diseases)
- Patient with haematological disease at risk of bleeding
- Patient with anal fistulas
- Patient unable to interrupt VKAs, OACs or APAs.
- Patient with an associated anal fissure
- External hemorrhoidal pathology
Show all 10Show fewer
- Patient participating in another clinical study
- Pregnant or lactating women
- Patient with pacemaker or implantable defibrillator
- Protected patient: adult under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
BLOMET clinic
Paris, IDF, 75015
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
Jean Francois OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
About this study
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.
The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.
Read more
The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.
In France, no studies have been carried out to evaluate this new technique.
Read the detailed description
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus (internal hemorrhoids). Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.
The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.
The use of a radiofrequency current (Rafaelo technique) in the treatment of hemorrhoidal disease is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.
Although radiofrequency destruction of hemorrhoidal vascular tissue is already used in other European countries such as Poland, Germany, Belgium and Great Britain, there are very few studies on this minimally invasive surgical technique. This is particularly the case in France where no studies have been carried out to evaluate this new technique.
- Conditions
- Hemorrhoids, Surgical Procedure, Unspecified
- Being tested
- Radiofrewuency surgery
- Keywords
- hemorrhoids, radiofrequency surgery
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrewuency surgeryProcedure or surgery
The research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue
| Study group | Role | What they receive |
|---|---|---|
| RF ARM | Experimental | The research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue Receives: Procedure: Radiofrewuency surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEMO-FISS-QoL
The primary endpoint for assessing changes in the patient's quality of life will be the total score obtained on the HEMO-FISS-QoL Quality of Life Questionnaire at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jul 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
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 HemorrhoidsStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Abramowitz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229784
- Sponsor's protocol ID
- 2018-A03220-55
- Acronym
- RF-GREP
- Status last verified
- Sep 2019
- First submitted
- 13 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laurain A, Bouchard D, Rouillon JM, Petit P, Liddo A, Vinson Bonnet B, Venara A, Didelot JM, Bonnaud G, Senejoux A, Higuero T, Delasalle P, Tarrerias AL, Devulder F, Castinel A, Thomas C, Pillant Le Moult H, Favreau-Weltzer C, Abramowitz L. French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease. Tech Coloproctol. 2023 Oct;27(10):873-883. doi: 10.1007/s10151-023-02787-1. Epub 2023 Apr 2.
PubMed 37005961
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
- ClinicalTrials.gov ID
- NCT04229784
- Acronym / sponsor ID
- RF-GREP / 2018-A03220-55
- Conditions
- Hemorrhoids, Surgical Procedure, Unspecified
- Keywords
- hemorrhoids, radiofrequency surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr Abramowitz
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.
The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.
The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.
In France, no studies have been carried out to evaluate this new technique.
Detailed description
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus (internal hemorrhoids). Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.
The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.
The use of a radiofrequency current (Rafaelo technique) in the treatment of hemorrhoidal disease is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.
Although radiofrequency destruction of hemorrhoidal vascular tissue is already used in other European countries such as Poland, Germany, Belgium and Great Britain, there are very few studies on this minimally invasive surgical technique. This is particularly the case in France where no studies have been carried out to evaluate this new technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF ARM | Experimental | Procedure: Radiofrewuency surgeryThe research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female consultant for a grade II or III haemorrhoidal pathology after failure of medical-instrumental treatments.
- Age > 18 years old and < 75 years old
- Patient having signed an informed consent
- Affiliate or beneficiary of a social security scheme
- For patients taking anti-vitamin K (AVK) or oral anticoagulants (OACs) a short stop will be recommended according to HAS recommendations.
Key exclusion criteria (10 listed)
- Patient with IBD (inflammatory bowel diseases)
- Patient with haematological disease at risk of bleeding
- Patient with anal fistulas
- Patient unable to interrupt VKAs, OACs or APAs.
- Patient with an associated anal fissure
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 |
|---|---|---|
| Radiofrewuency surgeryThe research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue | Procedure or surgery | RF ARM |
Primary outcome
HEMO-FISS-QoL
Time frame: 3 months
The primary endpoint for assessing changes in the patient's quality of life will be the total score obtained on the HEMO-FISS-QoL Quality of Life Questionnaire at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 37005961Laurain A, Bouchard D, Rouillon JM, Petit P, Liddo A, Vinson Bonnet B, Venara A, Didelot JM, Bonnaud G, Senejoux A, Higuero T, Delasalle P, Tarrerias AL, Devulder F, Castinel A, Thomas C, Pillant Le Moult H, Favreau-Weltzer C, Abramowitz L. French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease. Tech Coloproctol. 2023 Oct;27(10):873-883. doi: 10.1007/s10151-023-02787-1. Epub 2023 Apr 2.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrewuency surgery in people with Hemorrhoids and Surgical Procedure, Unspecified, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Barba (+330664888704 ext. +330664888704, mh.barba@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEMO-FISS-QoL (time frame: 3 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 NCT04229784, 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 18 Jan 2020.