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Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

NCT ID: NCT07161765

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bleeding Hemorrhoids Rectal Evacuation Disorders

Keywords

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Anorectal testing Rectal Expulsion Device (RED)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Rectal Expulsion Device

Group Type EXPERIMENTAL

Rectal Expulsion Device (RED)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids).
* Participants provider placed an order for anorectal manometry to the University of Michigan

Exclusion Criteria

* Anal fissure
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Eric Shah

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of MIchigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Brenda Ayala

Role: CONTACT

Phone: 734-936-4780

Email: [email protected]

Facility Contacts

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Brenda Ayala

Role: primary

Other Identifiers

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R03DK143921-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00275895

Identifier Type: -

Identifier Source: org_study_id