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A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

StatusCompleted
PhaseNot applicable
Started2025-08-20
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Trial status changed: Enrolling by Invitation → Completed
Final enrollment: 49 participants (planned 109)
Primary completion confirmed: September 2026 (last estimated February 2027)
2026-05-01
Study Status, Oversight, Eligibility v3
Eligibility criteria-20 characters
Inclusion Criteria Participants: - Participant has Chronic constipation as a main symptom Participant is able to participate in pelvic floor physical therapy Exclusion Criteria Participants: Participant has taken narcotic pain medication in the past [...] heduled for a test called an anorectal manometry in the past 12 months Participant has been scheduled to see a pelvic floor physical therapist in the past 12 months Participant is pregnant
2025-09-04
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2025-08→confirmed 2025-08-20
Study sitescontacts updated at 1 of 1 site
2025-06-24
Study Identification, Study Status v1
Study title-38 characters
Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2
2025-06-19
Original filing
This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.
Trial Details
NCT Number NCT07032376
Lead Sponsor University of Michigan
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Constipation
Enrollment 49 participants
Start Date 2025-08-20
Primary Completion 2026-09-04 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-25