New balloon device could spot hidden cause of constipation
NCT ID NCT04155307
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether a new device called EndoFLIP can better diagnose anismus, a condition where the anal muscles don't relax properly during bowel movements, causing severe constipation. Researchers measured anal stretchiness in 61 patients with chronic constipation and compared results to standard tests. If accurate, EndoFLIP could offer a simpler, more reliable diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anal EndoFLIP® device
- What this could lead to
- If successful, this could provide a more accurate and less invasive way to diagnose anismus, helping doctors choose the right treatment for chronic constipation.
- What could go wrong
- This is a small, completed study with 61 participants, so results may not apply to everyone. The device is still new and needs more testing before routine use.
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
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61 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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May 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * patient older than 18 years * patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level. * patient who read and signed the informed consent form Exclusion Criteria: * Patients with a predominant right of left colonic constipation; * Pregnant woman or woman with no effective contraception and of childbearing age * Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease. * Patient with anorectal malformation * Patient with an history of pelvic floor radiotherapy * Patient with a digestive stoma * Insertion of the probe impossible or painful * Patient who has participated to a clinical trial within 30 days prior to the inclusion visit * Patient not understanding or reading French * Patients under guardianship, curatorship, safeguard of justice * Patient without liberty by administrative or judicial decision
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rouen University Hospital
Rouen, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.