Rectal Expulsion Device for Hemorrhoid Bleeding

Overseen By Brenda Ayala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Anal fissure, Pregnancy

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Rectal Expulsion Device (RED) can identify individuals who might benefit from treatments for pelvic floor muscle issues, which often lead to straining and hemorrhoids. The goal is to improve treatment recommendations for those experiencing hemorrhoid bleeding. Individuals who have undergone a colonoscopy in the past year for rectal bleeding, with hemorrhoids as the only finding, may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance treatment options for pelvic floor issues.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Rectal Expulsion Device is safe for anorectal testing?

Research shows that the Rectal Expulsion Device (RED) is generally easy to use. Studies have found it to be a safe tool for assessing individuals with long-term constipation and hemorrhoidal bleeding. This device helps identify issues with the pelvic floor muscles, which can lead to straining and hemorrhoids.

No reports of serious side effects appear in the available data. The main focus is on its effectiveness in identifying evacuation problems, aiding doctors in determining the best treatment. Designed for use at the point of care, it aims to be user-friendly and cause minimal discomfort.

Overall, RED appears safe based on current information. However, as with any medical device, participating in a trial can provide more personal insights. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Rectal Expulsion Device (RED) because it offers a new approach for managing hemorrhoid bleeding. Unlike traditional treatments like topical creams or surgical procedures, this device works by facilitating the natural expulsion of blood from hemorrhoids, potentially reducing the need for invasive interventions. This method not only aims to provide immediate relief but also minimizes recovery time, making it a promising option for those seeking quick and efficient management of hemorrhoid symptoms.

What evidence suggests that the Rectal Expulsion Device is effective for hemorrhoid bleeding?

Research has shown that the Rectal Expulsion Device (RED), used by participants in this trial, could aid those with hemorrhoid bleeding and constipation. One study found that RED can identify individuals who might benefit from treatments for pelvic floor muscle issues. These muscles play a crucial role in bowel movements, and problems with them can lead to straining and hemorrhoids. The device serves as a quick test, enabling doctors to select the best treatment more efficiently. Early results suggest it has manageable side effects and could enhance treatment outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Eric Shah, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have been ordered anorectal manometry at the University of Michigan and experienced rectal bleeding with hemorrhoids as the only identified cause, confirmed by a colonoscopy within the last year. Pregnant individuals or those with anal fissures cannot participate.

Inclusion Criteria

Participants provider placed an order for anorectal manometry to the University of Michigan

I had a colonoscopy in the last year for rectal bleeding, and only hemorrhoids were found.

Exclusion Criteria

Pregnancy

I have an anal fissure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anorectal testing using the Rectal Expulsion Device (RED) to identify potential treatments for pelvic floor muscle problems

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rectal Expulsion Device (RED)

Trial Overview The study tests how a FDA-cleared Rectal Expulsion Device (RED) can identify patients whose pelvic floor muscle issues contribute to straining and hemorrhoid symptoms, potentially guiding more effective treatment options.

How Is the Trial Designed?

Group I: Rectal Expulsion Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. withpower.com withpower.com/trial/phase-hemorrhoids-8-2025-9886e

Rectal Expulsion Device for Hemorrhoid Bleeding ... Rectal Expulsion Device (RED) will have tolerable side effects & efficacy for patients with Constipation and Hemorrhoid Bleeding. Learn more about the study.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35341952/

An Office-Based, Point-of-Care Test Predicts Treatment ... We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor ...

3. red4constipation.com red4constipation.com/media/RED_Dr-Shah_Clinical_Paper.pdf

An Office-Based, Point-of-Care Test Predicts Treatment ... Accuracy of the rectal expulsion device (RED) to predict 12-week clinical response outcomes with pelvic floor physical therapy. Data are presented on a ...

4. neuraxis.com neuraxis.com/red/

RED - Rectal Expulsion Device Our aim was to provide an efficient, accurate, and cost-effective point of care tool to assess pelvic floor dysfunction and rectal ...

5. ctv.veeva.com ctv.veeva.com/study/rectal-evacuation-disorders-and-straining-associated-symptoms-in-bleeding-hemorrhoids

Rectal Evacuation Disorders and Straining-associated ... Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07161765

NCT07161765 | Rectal Evacuation Disorders and Straining ... Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids).

7. red4constipation.com red4constipation.com/

RED - A screening tool for patients with chronic constipation ... RED is a qualitative test to assess rectal hypersensitivity. RED, utilized as an expulsion device, can help screen for pelvic floor dysfunction in patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160215/

Development of a Simple, Point-of-Care Device to Test ... An easy-to-use, point-of-care device to rapidly screen for an evacuation disorder and immediately triage the 98% of patients with laxative-refractory chronic ...