[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501289":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":32,"responsibleParty":72,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":11,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The California Medical Innovations Institute, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecobionics","EXPERIMENTAL",null,[13],"Device: Fecobionics",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.",[9],[20,21],"Anorectal manometry","Balloon expulsive test",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Hans Gregersen, PhD","CONTACT","858-249-7400","hag@giome.org",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},"Satish Rao, MD, PhD","706-7212238","srao@augusta.edu",[33,58],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"California Medical Innovations Institute","RECRUITING","San Diego","California","92121","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-117.16472,32.71571,{"lat":45,"lon":44},[48,49,52,55],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},{"name":50,"role":25,"phone":26,"phoneExt":11,"email":51},"Ghassan Kassab, PhD","gkassab@calmi2.org",{"name":53,"role":54,"phone":11,"phoneExt":11,"email":11},"Lucy G Barron Del Solar, MD","SUB_INVESTIGATOR",{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Hans Gregersen, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":35,"city":60,"state":61,"zip":62,"country":39,"countryCode":40,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Digestive Health Center- Augusta University","Augusta","Georgia","30912",{"type":42,"coordinates":64},[65,66],-81.97484,33.47097,{"lat":66,"lon":65},[69],{"name":70,"role":25,"phone":71,"phoneExt":11,"email":31},"Satish Rao, MD, Phd","706-721-2239",{"type":57,"investigatorFullName":24,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"CEO",[75,77],{"name":76,"class":6},"Scripps Clinic",{"name":78,"class":79},"Augusta University Medical Center","UNKNOWN","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":91,"type":92},24,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98,99],"Dyssynergia","Constipation",[9,101,102],"Biofeedback therapy","Defecation","2025-10-20",{"date":105,"type":106},"2025-10-21","ACTUAL",{"date":108,"type":106},"2023-10-03",{"date":110,"type":92},"2027-03-31",{"name":5,"class":6},2]