MedTrace Logo

Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

NCT07161765 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-12

No results posted yet for this study

Summary

This study aims to understand the mechanisms of straining on anorectal testing, to better help people receive more effective treatment advice. The study also aims to understand how point-of-care anorectal testing with an FDA-cleared device called Rectal Expulsion Device (RED) helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.

Conditions

  • Bleeding Hemorrhoids
  • Rectal Evacuation Disorders

Interventions

DEVICE

Rectal Expulsion Device (RED)

Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan. Gastroenterology staff will perform the RED device at the time of a participant's anorectal manometry appointment.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Eric Shah, MD · University of Michigan

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07161765 on ClinicalTrials.gov