ConstipationNCT07032376
A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation
A study testing Survey and Rectal Expulsion Device use in people with Constipation, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Survey and Rectal Expulsion Device use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 4 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has Chronic constipation as a main symptom
Who cannot join
- Participant has taken narcotic pain medication in the past 30 days
- Participant has been scheduled 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2
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.
Read the detailed description
This registration is (Implementation Phase) for the registered study "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.
- Conditions
- Constipation
- Being tested
- Survey, Rectal Expulsion Device use
- Keywords
- Questionnaires, Gastroenterology care, Rectal Expulsion Device (RED)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
All participants will complete a baseline survey and have medical information collected.
Rectal Expulsion Device useBehavioural
During the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit.
In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED.
| Study group | Role | What they receive |
|---|---|---|
| Chronic constipation | Experimental | Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit. Receives: Behavioral: Survey; Behavioral: Rectal Expulsion Device use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
Fidelity to ordering pelvic floor diagnostics
Measured: Day 1 (Baseline = initial appointment after consent)]
Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment
Fidelity to ordering pelvic floor treatment
Measured: Day 1 (Baseline = initial appointment after consent)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start20 Aug 2025
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Shah, University of Michigan
- Investigators
- Eric Shah, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032376
- Sponsor's protocol ID
- HUM00228948b
- Other IDs
- 1K23DK134752-01
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation- Phase 2
- ClinicalTrials.gov ID
- NCT07032376
- Acronym / sponsor ID
- HUM00228948b
- Conditions
- Constipation
- Keywords
- Questionnaires, Gastroenterology care, Rectal Expulsion Device (RED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This registration is (Implementation Phase) for the registered study "Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation" (Observational Phase) NCT06352827.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic constipation | Experimental | Behavioral: Survey, Behavioral: Rectal Expulsion Device useParticipants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant has Chronic constipation as a main symptom
Key exclusion criteria (4 listed)
- Participant has taken narcotic pain medication in the past 30 days
- Participant has been scheduled 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAll participants will complete a baseline survey and have medical information collected. | Behavioural | Chronic constipation |
| Rectal Expulsion Device useDuring the participant's clinic visit for constipation, the Rectal Expulsion Device will be available for the gastroenterology care provider to use if the decision is made to use this during the clinic visit. In addition, the care provider will have access to the RED brochure and the Michigan Chart (MICHART) Our Practice Advisory (OPA) - a decision support tool in MiChart to support care navigation using RED. | Behavioural | Chronic constipation |
Primary outcome
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment
Time frame: Day 1 (Baseline = initial appointment after consent)]
Fidelity to ordering pelvic floor diagnostics
Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment
Time frame: Day 1 (Baseline = initial appointment after consent)]
Fidelity to ordering pelvic floor treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Shah, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey and Rectal Expulsion Device use in people with Constipation, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment (time frame: Day 1 (Baseline = initial appointment after consent)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.