NCT07161765

Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-09-09
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study