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Smart 'Poop' device could revolutionize constipation care

NCT ID NCT04903470

Knowledge-focused Sponsor: The California Medical Innovations Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called Fecobionics, which looks and feels like a normal stool, to better understand how people with chronic constipation defecate. Researchers will measure pressures and movements in the rectum and anal canal in 130 healthy volunteers and constipated patients. They will also use drugs that speed up or slow down bowel movements to see how the device detects changes. The goal is to improve diagnosis and guide future treatments for constipation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bisacodyl and Atropine
What this could lead to
If successful, this research could lead to better diagnostic tools and more effective treatments for chronic constipation.
What could go wrong
This is an early-stage observational study with only 130 participants, so results may not apply to everyone. The device is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Two groups of subjects will be studied - normal healthy subjects and patients with chronic constipation. Normal subjects: Inclusion criteria \*Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation. Exclusion Criteria: * Subjects not willing to consent and undergo the specified tests in this study * Pregnant women * Subjects with concurrent fecal incontinence and constipation symptoms * Chronic diseases * Taking medications that affect anorectal function * History of anorectal surgery or bowel resection. Constipation patients: Inclusion Criteria: * Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months: 1. Fewer than three spontaneous bowel movements per week, 2. Straining for more than 25% of defecation attempts, 3. Lumpy or hard stools for at least 25% of defecation attempts, and 4. sensation of anorectal obstruction or blockage. \- Exclusion Criteria: * Patients not willing to consent and undergo the specified tests in this study * pregnant women and patients with concurrent fecal incontinence * History of anorectal surgery or bowel resection.

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Conditions

The condition(s) this trial relates to.

constipation disorder outlet dysfunction constipation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation by outlet obstruction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • California Medical Innovations Institute

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92121, United States

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