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NCT04766138 · ClinicalTrials.gov registry record · NA
Trial to Evaluate Fecobionics in Healthy Subjects and Patients
A NA study, sponsored by The California Medical Innovations Institute.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT04766138: Completed NA study, sponsored by The California Medical Innovations Institute.
NCT04766138 is a NA study that has completed, run by The California Medical Innovations Institute. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04766138, a NA study, has completed, sponsored by The California Medical Innovations Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal. The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only.
Primary Outcome
Expulsion Duration - The time it takes to defecate Fecobionics
Interventions
- DEVICE Fecobionics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-03-09 |
| Phase | NA |
What the finished NCT04766138 record still lists
NCT04766138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecobionics is the first listed.
NCT04766138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04766138 about?
NCT04766138 is a clinical study titled "Trial to Evaluate Fecobionics in Healthy Subjects and Patients". Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possi...
What is the current status of trial NCT04766138?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2021-01-01. Estimated completion is 2023-03-09.
What interventions are being tested in trial NCT04766138?
The interventions under investigation include: Fecobionics (DEVICE).
Who is sponsoring clinical trial NCT04766138?
This trial is sponsored by The California Medical Innovations Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04766138's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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