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New device sheds light on bowel function in healthy adults

NCT ID NCT04766138

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new device called Fecobionics in 35 healthy adults to better understand how defecation works. The device is inserted into the rectum and measures pressure, angle, and timing during bowel movements. The goal is to gather normal data that could help diagnose and treat conditions like fecal incontinence in the future.

What this could mean

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

Active substance
Fecobionics device
What this could lead to
If successful, this could provide a better way to diagnose and monitor bowel disorders like fecal incontinence.
What could go wrong
This is a small, early study in healthy people only, so results may not apply to patients or lead to immediate treatments.

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

35 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2023

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

18 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.

For Normal Subjects (in California Medical Innovations Institute): Inclusion Criteria: 1. Subject must provide written informed consent; 2. Age 18 years and of age of legal consent; 3. Normal defecation pattern; 4. Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores. Exclusion Criteria: 1. Female, who is pregnant or lactating; 2. Prior abdominal surgery; 3. Diagnosis of fecal incontinence, constipation or anorectal pain. For Patients with Fecal Incontinence (in University of California, San Diego): Inclusion Criteria: 1. Subject must provide written informed consent; 2. Age 18 years and of age of legal consent; 3. Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment Exclusion Criteria: 1. Female, who is pregnant or lactating; 2. Prior abdominal surgery

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence

As listed by the trial registrant

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

Fecal incontinence Normal subjects

Contacts and locations

Locations

  • California Medical Innovations Institute

    San Diego, California, 92121, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.