Normal SubjectsNORMALNCT04766138
Trial to Evaluate Fecobionics in Healthy Subjects and Patients
A study testing Fecobionics in people with Normal Subjects and Fecal Incontinence, run by The California Medical Innovations Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Subjects, Fecal Incontinence
- What is being tested?
- Fecobionics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent;
- Age 18 years and of age of legal consent;
- Normal defecation pattern;
- Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores.
- Subject must provide written informed consent;
- Age 18 years and of age of legal consent;
- Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment
Who cannot join
- Female, who is pregnant or lactating;
- Prior abdominal surgery;
- Diagnosis of fecal incontinence, constipation or anorectal pain.
- For Patients with Fecal Incontinence (in University of California, San Diego):
- Female, who is pregnant or lactating;
- Prior abdominal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
California Medical Innovations Institute
San Diego, California, 92121
About this study
Official title: Neurophysiological Mechanism in Sacral Neuromodulation in Patients Suffering From Fecal Incontinence
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.
Read the detailed description
Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors. The homeostatic balance is easily disturbed by functional or structural anorectal disturbances that may coexist. Common anorectal disorders are fecal incontinence, functional anorectal pain, and functional defecation disorders. These conditions greatly affect life quality for the patients. Current technologies for anorectal functional assessment studies have limitations and often overlap is found between patient groups with lack of correlation between measurements and symptoms. Defecation physiology has been studied for many years but the mechanics and mechanosensation of defecation are still not well understood.
Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development of Fecobionics was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as close 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 as well as other parameters
The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. Fecobionics 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, i.e. studying mechanisms of defecation.
- Conditions
- Normal Subjects, Fecal Incontinence
- Being tested
- Fecobionics
- Keywords
- anorectal, Fecobionics, defecation, bionics
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FecobionicsDevice
Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation
| Study group | Role | What they receive |
|---|---|---|
| Fecobionics studies | Experimental | Single-arm study Receives: Device: Fecobionics |
| Feco BFT | Active comparator | In this ARM Fecobionics will be used as a BFT tool Receives: Device: Fecobionics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration-based device expulsion parameters
Expulsion Duration - The time it takes to defecate Fecobionics
Measured: 1 year
Pressure-based device expulsion parameters
Pressure difference between front and rear of Fecobionics device - A measure of anal sphincter relaxation and key to the determination of defecation phases. Pressure profiles
Measured: 1 year
Secondary outcomes (3)
Mechanical-based expulsion parameters Endpoints
Mechanical Tension of Fecobionics Device (Pressure multiplied with radius).
Measured: 1 year
Device orientation and bending-based expulsion parameters
orientation of the device (degrees) and bending angle (degrees, a proxy of the anorectal angle during defecation)
Measured: 1 year
Shape-based expulsion parameters
bag shape during defecation. Topographic characteristics of Fecobionics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Jan 2021
- Primary completion9 Dec 2022
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The California Medical Innovations Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Hans Gregersen, PhD, The California Medical Innovations Institute, Inc.
- Investigators
- Hans Gregersen, PhD, Principal investigator, California Medical Innovations Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766138
- Sponsor's protocol ID
- CALMI-CLIN-2019-01
- Acronym
- NORMAL
- Status last verified
- Oct 2025
- First submitted
- 2 Aug 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Mechanism in Sacral Neuromodulation in Patients Suffering From Fecal Incontinence
- ClinicalTrials.gov ID
- NCT04766138
- Acronym / sponsor ID
- NORMAL / CALMI-CLIN-2019-01
- Conditions
- Normal Subjects, Fecal Incontinence
- Keywords
- anorectal, Fecobionics, defecation, bionics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The California Medical Innovations Institute, Inc.University, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors. The homeostatic balance is easily disturbed by functional or structural anorectal disturbances that may coexist. Common anorectal disorders are fecal incontinence, functional anorectal pain, and functional defecation disorders. These conditions greatly affect life quality for the patients. Current technologies for anorectal functional assessment studies have limitations and often overlap is found between patient groups with lack of correlation between measurements and symptoms. Defecation physiology has been studied for many years but the mechanics and mechanosensation of defecation are still not well understood.
Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development of Fecobionics was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as close 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 as well as other parameters
The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. Fecobionics 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, i.e. studying mechanisms of defecation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecobionics studies | Experimental | Device: FecobionicsSingle-arm study |
| Feco BFT | Active comparator | Device: FecobionicsIn this ARM Fecobionics will be used as a BFT tool |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must provide written informed consent;
- Age 18 years and of age of legal consent;
- Normal defecation pattern;
- Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores.
- Subject must provide written informed consent;
Key exclusion criteria (6 listed)
- Female, who is pregnant or lactating;
- Prior abdominal surgery;
- Diagnosis of fecal incontinence, constipation or anorectal pain.
- Female, who is pregnant or lactating;
- Prior abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FecobionicsFecobionics is a new device to be inserted through the anal canal into rectum for studying defecation | Device | Feco BFT, Fecobionics studies |
Primary outcome
Duration-based device expulsion parameters
Time frame: 1 year
Expulsion Duration - The time it takes to defecate Fecobionics
Pressure-based device expulsion parameters
Time frame: 1 year
Pressure difference between front and rear of Fecobionics device - A measure of anal sphincter relaxation and key to the determination of defecation phases. Pressure profiles
3 secondary outcomes
Mechanical-based expulsion parameters Endpoints
Time frame: 1 year
Device orientation and bending-based expulsion parameters
Time frame: 1 year
Shape-based expulsion parameters
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gregersen, PhD principal investigator
California Medical Innovations Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecobionics in people with Normal Subjects and Fecal Incontinence, run by The California Medical Innovations Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration-based device expulsion parameters (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.