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New treatment option for Internal Hemorrhoids
Official title Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
ClinicalTrials.gov ID: NCT07179601
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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
- Refusal of or contraindication to other minimally invasive hemorrhoid treatments
You likely can't join if
- Asymptomatic patients
- Patients who ever had previous colorectal surgery
- Grade IV hemorrhoids
- Colorectal disease other than hemorrhoids that could result in bleeding
- Anatomic findings on CTA that would preclude successful embolization
- Contraindication to iodinated contrast
See the full eligibility criteria
- 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
- Refusal of or contraindication to other minimally invasive hemorrhoid treatments
- Grade I to III hemorrhoids
- Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year
- Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization
- Asymptomatic patients
- Patients who ever had previous colorectal surgery
- Grade IV hemorrhoids
- Colorectal disease other than hemorrhoids that could result in bleeding
- Anatomic findings on CTA that would preclude successful embolization
- Contraindication to iodinated contrast
- Inability to give written informed consent
- Active infection or malignancy
- Recent (within 12 months) or active cigarette use
- History of inflammatory bowel disease
- Uncorrectable bleeding diathesis
- Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy
- No SRA or MRA supply to the CCR seen intra-procedural angiogram
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. 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.