Arterial Embolization vs Band Ligation for Hemorrhoids

(STRATOS Trial)

Overseen By Saima Chaabane, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jessica K. Stewart, MD

Disqualifiers: Kidney dysfunction, Atherosclerosis, GI bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life.

HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation.

RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.

Who Is on the Research Team?

Dennis Jensen, MD

Principal Investigator

University of California, Los Angeles

Jessica Stewart, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Inclusion Criteria

I still have bleeding hemorrhoids after trying standard home treatments.

I am between 18 and 89 years old.

2. Ability to provide written informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either hemorrhoidal artery embolization or rubber band ligation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1 week, 1 month, 2 months, 3 months, 6 months, and 12 months

Crossover (optional)

Participants may crossover to the other treatment modality at 6 months if bleeding continues

6-12 months

Follow-up visits similar to initial treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• Hemorrhoidal Artery Embolization
• Rubber Band Ligation

How Is the Trial Designed?

Group I: Hemorrhoidal Artery Embolization Active Control 1 Intervention

Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.

Group II: Rubber Band Ligation Active Control 1 Intervention

Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

Who Is Running the Clinical Trial?

Jessica K. Stewart, MD

Lead Sponsor

Terumo Medical Corporation

Industry Sponsor

Trials

25

Recruited

10,400+