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New treatment option for Hemorrhoids
Official title Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease
ClinicalTrials.gov ID: NCT05697562
What this study is testing
- What it's testing
- SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥ 5.
- Age \> 18 years old;
- Sexes eligible for study: all
- Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
- History of prior instrumental treatment of HD does not prohibit inclusion
You likely can't join if
- Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
- Rectal prolapse
- History of proctological surgery for HD
- Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
- Anal stenosis, congenital of acquired
- Chronic anal fissure
See the full eligibility criteria
- All patients referred for Hemorrhoidal disease with bleeding are eligible. Significant bleeding is defined as a HBS of ≥ 5.
- Age \> 18 years old;
- Sexes eligible for study: all
- Hemorrhoidal disease grade I-III according the Goligher classification with rectal bleeding as predominant symptom
- History of prior instrumental treatment of HD does not prohibit inclusion
- Able to understand and read Dutch, French or English
- Permanent hemorrhoidal prolapse/grade IV hemorrhoidal disease
- Rectal prolapse
- History of proctological surgery for HD
- Acute complicated course of HD i.e. acute thrombosis (fluxio hemorrhoidalis or perianal hematoma)
- Anal stenosis, congenital of acquired
- Chronic anal fissure
- Active rectal inflammation, including peri-anal abscess (e.g. Inflammatory Bowel Disease, infectious,…)
- History of colorectal or anal cancer
- History of rectal or sigmoidal resection
- Portal hypertension and liver cirrhosis Child Pugh C
- Radiation rectitis
- Neurological disease involving anal sphincter musculature
- Severe psychiatric disorder
- Pregnancy
- Allergy to iodinated contrast agents
- Colorectal neoplasia as the cause of bleeding (excluded with a (virtual) colonoscopy in the last year)
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.