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Smart poop device could revolutionize gut disorder diagnosis

NCT ID NCT03317938

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new device called Fecobionics, which acts like artificial stool, to better understand and diagnose chronic constipation and fecal incontinence. Researchers studied 236 people, including patients and healthy volunteers, to see if the device can provide clearer information about how the bowel works. The goal is to improve diagnosis and eventually lead to better treatments for these common conditions.

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 lead to better, simpler diagnostic tools for common bowel disorders, improving how doctors identify and treat these conditions.
What could go wrong
This is an observational study, not a treatment trial. The device is still being tested, and it may not prove more useful than existing methods.

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

236 people

The number who actually took part.

Started

Aug 2017

Finished

Dec 2024

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 years and older

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: * Healthy subjects: Asymptomatic healthy persons aged over 18 years who can give informed consent. * CC (Chronic Constipation) Patients: Patients over 18 with history of FI for over 3months, who are able to give consent. * FI (Fecal Incontinence) patients: Patients over 18 with history of FI for over 3months, who are able to give consent. * Patients with a stoma who are over 18 years and able to give consent. Exclusion Criteria: * Healthy subjects: Persons with a history of constipation or fecal incontinence, prior abdominal surgery, medication, and diseases, especially chronic diseases that affect bowel function and defecation. Pregnant women will also be excluded. * CC Patients: Patients, who are not willing to undergo the proposed test program and patients with prior anorectal or intestinal surgery. Pregnant women and patients with chronic dehydration and on medications like opioids will also be excluded. * FI patients: 1) Patients who are not willing to undergo the specified tests in this study, 2) Pregnant women and 3) Patients who has had anorectal surgery or bowel resection. * Patients with stoma: Patients, who are not willing to undergo the proposed test program and patients who have inflammation or symptoms related to the stoma.

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Conditions

The condition(s) this trial relates to.

constipation disorder Fecal Incontinence

As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Surgery, Prince of Wales Hospital

    Hong Kong, 0000, Hong Kong

  • Prince of Wales Hospital

    Hong Kong, Hong Kong, 000000, Hong Kong

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