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Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)

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ClinicalTrials.gov Identifier: NCT05412069
Recruitment Status : Not yet recruiting
First Posted : June 9, 2022
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Augusta University Medical Center
Information provided by (Responsible Party):
Hans Gregersen, PhD, The California Medical Innovations Institute, Inc.

Brief Summary:

The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. 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 (BET and FECOM) 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 normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction.


Condition or disease Intervention/treatment Phase
Normal Subjects Fecal Incontinence Device: Fecobionics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecobionics study
Fecobionics
Device: Fecobionics
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry, balloon expulsion test, and anal ultrasonography will be used as reference.
Other Names:
  • anorectal manometry
  • balloon expulsion test
  • anal ultrasonography




Primary Outcome Measures :
  1. Length-tension properties of the anal sphincter will be reported [ Time Frame: 1 year ]
  2. Front-rear pressure difference (in cmH2O) will be measured [ Time Frame: 1 year ]
    Fecobionics contain pressure sensors in front end and rear end which can measure pressures


Secondary Outcome Measures :
  1. Anorectal angle (in degree) will be measured [ Time Frame: 1 year ]
    Fecobionics contain motion processing units with gyroscopes and accelerometers, which can measure angles

  2. Expulsion velocity (in mm/s) will be reported [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must provide written informed consent;
  2. Willing and able to undergo required study tests, surveys, and procedures;
  3. Age > 18 and < 75 years of age.

Exclusion Criteria:

  1. Female who is pregnant;
  2. Prior anorectal surgery;
  3. Prior bowel resection;
  4. History of chronic constipation;
  5. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05412069


Contacts
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Contact: Hans Gregersen, MD, PhD 8582497400 hag@giome.org
Contact: Satish Rao, MD, PhD 7067212238 srao@augusta.edu

Locations
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United States, California
California Medical Innovations Institute
San Diego, California, United States, 92121
Contact: Hans Gregersen, PhD    858-249-7400    hag@giome.org   
Contact: Ghassan Kassab, PhD    8582497400    gkassab@calmi2.org   
Sub-Investigator: Yanmin Wang, MD, PhD         
United States, Georgia
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Contact: Satish Rao, MD, PhD    706-721-2238    srao@augusta.edu   
Contact: Tennekoon Karunaratne, MD, PhD    7067211968    tkarunaratne@augusta.edu   
Sponsors and Collaborators
The California Medical Innovations Institute, Inc.
Augusta University Medical Center
Investigators
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Principal Investigator: Hans Gregersen, MD, PhD California Medical Innovations Institute
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Responsible Party: Hans Gregersen, PhD, Research Professor, The California Medical Innovations Institute, Inc.
ClinicalTrials.gov Identifier: NCT05412069    
Other Study ID Numbers: CALM-CLIN-2022 new
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Gregersen, PhD, The California Medical Innovations Institute, Inc.:
anorectal
Fecobionics
defecation
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases