Rectal Expulsion Device for Constipation

Overseen By Brenda Ayala

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Narcotic pain medications

Disqualifiers: Pregnancy, Anorectal manometry, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Rectal Expulsion Device (RED) can assist doctors in understanding constipation during regular office visits. Participants will complete a survey and may use this FDA-cleared device during their check-up. The device aims to simplify and enhance the diagnosis and management of constipation. Individuals with chronic constipation who can participate in pelvic floor physical therapy might be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to innovative research that could advance constipation diagnosis and management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken narcotic pain medication in the past 30 days, you cannot participate.

What prior data suggests that the Rectal Expulsion Device is safe for evaluating constipation?

Research has shown that the Rectal Expulsion Device (RED) is generally safe to use. In a safety study, 4.6% of participants felt a vibration, 1.8% experienced stomach pain, and 0.64% had diarrhea. These side effects were mild and uncommon. The FDA has approved the device, indicating it meets safety standards for medical use. Most people using it for constipation have tolerated it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rectal Expulsion Device is unique because it offers a new mechanical approach to managing chronic constipation, different from the usual reliance on medications like laxatives or stool softeners. Unlike standard treatments that focus on chemically altering stool consistency or stimulating bowel movements, this device directly assists in the physical expulsion of stool. Researchers are excited about this because it provides an option that works immediately during a clinic visit without the need for ongoing medication, potentially reducing dependency on drugs and their associated side effects.

What evidence suggests that the Rectal Expulsion Device is effective for evaluating constipation?

Research has shown that the Rectal Expulsion Device (RED), which participants in this trial may use, helps diagnose and predict treatment outcomes for people with chronic constipation. Studies have found that RED assists doctors in identifying patients who might benefit from pelvic floor physical therapy. This enables doctors to choose treatment options more quickly than other methods. The FDA has approved the device, indicating it meets safety standards. While it doesn't directly treat constipation, it aids in planning effective treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Eric Shah, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic constipation who are seeking care. Participants will use an FDA-cleared device called Rectal Expulsion Device (RED) during a routine office visit and complete a survey. Specific eligibility criteria were not provided.

Inclusion Criteria

My main symptom is chronic constipation.

I can do pelvic floor physical therapy.

Exclusion Criteria

Participant is pregnant

I have been scheduled to see a pelvic floor physical therapist before.

Participant has been scheduled for a test called an anorectal manometry in the past

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Implementation

Participants complete surveys and may have the Rectal Expulsion Device used during their routine office visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial appointment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rectal Expulsion Device
• Survey

Trial Overview The study is testing the effectiveness of using the RED to evaluate constipation in patients during their regular doctor's appointment, along with completing a health-related survey.

How Is the Trial Designed?

Group I: Chronic constipation Experimental Treatment 2 Interventions

Participants will complete surveys and may or may not have the Rectal Expulsion Device (FDA 510k approved) used during clinic visit.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. cghjournal.org cghjournal.org/article/S1542-3565(22)00297-X/fulltext

An Office-Based, Point-of-Care Test Predicts Treatment ... An office-based, point-of-care test predicts treatment outcomes with community-based pelvic floor physical therapy in patients with chronic constipation.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35341952/

An Office-Based, Point-of-Care Test Predicts Treatment ... We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S154235652200297X

An Office-Based, Point-of-Care Test Predicts Treatment ... We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor ...

4. gastro.org gastro.org/news/fda-approves-gi-device-developed-by-two-aga-members/

FDA approves device developed by AGA research scholar The Rectal Expulsion Device (RED), allows clinicians to diagnose and predict treatment outcomes for individuals with chronic constipation earlier than other ...

5. geiselmed.dartmouth.edu geiselmed.dartmouth.edu/news/2022/rectal-expulsion-device-may-predict-outcomes-in-patients-with-chronic-constipation-healio/

Rectal Expulsion Device May Predict Outcomes in Patients ... Rectal Expulsion Device May Predict Outcomes in Patients With Chronic Constipation – Healio ... data he presented at Digestive Disease Week ...

6. healio.com healio.com/news/primary-care/20220616/top-in-gi-rectal-expulsion-device-percutaneous-vs-endoscopic-ultrasound-biopsy

Top in GI: Rectal expulsion device; percutaneous vs. ... Rectal expulsion device may predict outcomes in patients with chronic constipation. An investigational, point-of-care rectal expulsion device ...

7. journals.lww.com journals.lww.com/ctg/fulltext/9900/real_world_evidence_of_the_long_term_clinical.459.aspx

Real-World Evidence of the Long-Term Clinical Utility of a... Safety analysis revealed that 4.6% of patients reported feeling a sensation of vibration, 1.8% reported abdominal pain and 0.64% reported diarrhea. DISCUSSION:.

8. neuraxis.com neuraxis.com/red/

RED - Rectal Expulsion Device A screening tool for patients with chronic constipation. RED was designed to provide a simple screening tool that broadly detects evacuation ...