[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The California Medical Innovations Institute, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100501289","fecobionics-in-biofeedback-therapy-in-dyssynergia-patients-100501289",false,"NCT05807321","Fecobionics in Biofeedback Therapy in Dyssynergia Patients","Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients","Inclusion Criteria:\n\n1. Subject must provide written informed consent.\n2. Age between 21-75 years.\n3. Subjects must fulfill the criteria for obstructed defecation\u002Fdyssynergia and enter the BFT at UCSD or Scripps.\n\nExclusion Criteria:\n\n1. Female who is pregnant or lactating.\n2. Prior abdominal or anorectal surgery or bowel resection.\n3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.\n4. Confirmed or suspected COVID-19 infection.\n5. Severe cardiovascular disease.\n6. Subjects not willing to consent and undergo the specified tests in this study.\n7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.","ALL","21 Years","75 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.",[27,28],"Dyssynergia","Constipation",[30,31,32],"Fecobionics","Biofeedback therapy","Defecation","RECRUITING","2025-10-20",{"date":36,"type":37},"2025-10-21","ACTUAL",{"date":39,"type":37},"2023-10-03",{"date":41,"type":21},"2027-03-31",{"name":43,"class":44},"The California Medical Innovations Institute, Inc.","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":45},"100470915","trial-to-evaluate-fecobionics-in-fecal-incontinence-fi-normal-and-abnormal-fi-100470915","NCT05412069","Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)","A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)","Inclusion Criteria:\n\n1. Subject must provide written informed consent;\n2. Willing and able to undergo required study tests, surveys, and procedures;\n3. Age \\> 18 years of age.\n\nExclusion Criteria:\n\n1. Female who is pregnant;\n2. Prior anorectal surgery;\n3. Prior bowel resection;\n4. History of chronic constipation;\n5. In the opinion of the investigator, the subject is not a suitable candidate for the study.",true,"18 Years",{"count":56,"type":21},155,[24],"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.\n\nThe 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.",[60,61],"Normal Subjects","Fecal Incontinence",[63,30,64],"anorectal","defecation",{"date":36,"type":37},{"date":67,"type":37},"2023-02-15",{"date":41,"type":21},{"name":43,"class":44},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":45},"100431850","defecation-patterns-in-constipated-patients-100431850","NCT04903470","Defecation Patterns in Constipated Patients","Understanding Defecation Patterns Using a Novel Device (Fecobionics) to Improve Treatment of Constipation","Inclusion Criteria: Two groups of subjects will be studied - normal healthy subjects and patients with chronic constipation.\n\nNormal subjects:\n\nInclusion criteria \\*Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.\n\nExclusion Criteria:\n\n* Subjects not willing to consent and undergo the specified tests in this study\n* Pregnant women\n* Subjects with concurrent fecal incontinence and constipation symptoms\n* Chronic diseases\n* Taking medications that affect anorectal function\n* History of anorectal surgery or bowel resection.\n\nConstipation patients:\n\nInclusion Criteria:\n\n* Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months:\n\n  1. Fewer than three spontaneous bowel movements per week,\n  2. Straining for more than 25% of defecation attempts,\n  3. Lumpy or hard stools for at least 25% of defecation attempts, and\n  4. sensation of anorectal obstruction or blockage.\n\n     \\-\n\n     Exclusion Criteria:\n* Patients not willing to consent and undergo the specified tests in this study\n* pregnant women and patients with concurrent fecal incontinence\n* History of anorectal surgery or bowel resection.",{"count":78,"type":21},130,[24],"Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction\u002Fperistalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex\u002Fprocess in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.",[82],"Constipation by Outlet Obstruction",[84,85,86,87,88],"Obstructed defecation","Pelvic floor dysynergia","Paradoxical contraction of the anal sphincter","Anorectal motility","Impedance planimetry of anal sphincter",{"date":36,"type":37},{"date":91,"type":37},"2022-12-19",{"date":93,"type":21},"2026-12-30",{"name":43,"class":44},""]