Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of California, Los Angeles
About this trial
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.
Eligibility criteria
Qualifiers
Age 18 to 90 years
Ability to give written informed consent and to comply with the follow-up visits
Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
Refusal of or contraindication to surgery
Disqualifiers
Asymptomatic patients
Patients who ever had previous colorectal surgery
Grade IV hemorrhoids
Colorectal disease other than hemorrhoids that could result in bleeding
Trial design
Treatments tested in this trial
- Hemorrhoidal artery embolization
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov