[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602654":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":61,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Coloplast A\u002FS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Exploratory single-arm interventional investigation","EXPERIMENTAL","Prescription of Peristeen Light transanal irrigation system at enrolment to use for a 12 week test period",[13],"Device: Peristeen Light - trans anal irrigation system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Peristeen Light - trans anal irrigation system","Subjects naive to TAI will use Peristeen Light trans anal irrigation",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Michel Briand de Crevecoeur","CONTACT","+4549111272","dkmibc@coloplast.com",[28,46],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Århus University Hospital","RECRUITING","Aarhus","Gotland","8200","Denmark","DK",{"type":37,"coordinates":38},"Point",[39,40],10.21076,56.15674,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":20,"phoneExt":20,"email":45},"Peter Christensen, Professor, DMSci","petchris@rm.dk",{"facility":47,"status":30,"city":48,"state":20,"zip":20,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Montecatone Rehabillitation Institute S.p.A","Bologna","Italy","IT",{"type":37,"coordinates":52},[53,54],11.33875,44.49381,{"lat":54,"lon":53},[57],{"name":58,"role":24,"phone":59,"phoneExt":20,"email":60},"Gabriele Bazzocchi, M.D., Ph.D., A.G.A.F","+39 347 440 7018","gabriele.bazzocchi@unibo.it",{"type":62,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100602654","peristeen-light-explorative-clinical-investigation-100602654",false,"NCT07126327","Peristeen Light Explorative Clinical Investigation","An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light","Inclusion Criteria:\n\n* Has given written informed consent\n* Is at least 18 years old\n* Has full legal capacity\n* Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration\n* Has access to and is able to use a smartphone\n* Has constipation and\u002For faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction\u002Fblockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and\u002For stool)\n* Is assessed (by investigator) to have a need for low-volume TAI minimum every other day\n\nExclusion Criteria:\n\n* Is participating in any other clinical investigation during this investigation\n* Has previously completed this investigation\n* Is former or current user of transanal irrigation (low- and high volume)\n* Has known hypersensitivity towards the device used in the investigation\n* Is pregnant\n* Has known anal stenosis\n* Has active\u002Frecurrent colorectal cancer\n* Has had anastomotic colorectal surgery within the last 3 months\n* Has ischaemic colitis\n* Has active inflammatory bowel disease\n* Has acute diverticulitis or diverticular abscess\n* Has medicine induced constipation (e.g. due to opioids)\n* Has chronic diarrhea\n* Has bowel dysfunction due to neurogenic disorder(s)\n* Is in need of high-volume TAI (as estimated by investigator)","ALL","18 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and\u002For time-consuming bowel management procedures.\n\nThe primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.",[80,81],"Faecal Incontinence","Constipation - Functional",[83],"trans anal irrigation","2026-04-13",{"date":86,"type":87},"2026-04-14","ACTUAL",{"date":89,"type":87},"2025-11-10",{"date":91,"type":74},"2026-08-01",{"name":5,"class":6},2]