[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547508":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":32,"locations":42,"responsibleParty":58,"collaborators":60,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":10,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":10,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":96,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"normal transit constipation group",null,"Patients with confirmed normal transit constipation.",[13],"Device: Vibrabot capsule",{"label":15,"type":10,"description":16,"interventionNames":17},"dyssynergic defecation group","Patients with confirmed dyssynergic defecation.(abnormal balloon expulsion test and\u002For high anal sphincter pressure and\u002For failure of the anorectal angle to open)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"slow-transit constipation group","Patients with confirmed slow-transit constipation.(diagnosed by colon transit scintigraphy)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"slow-transit constipation + dyssynergic defecation","Patients with confirmed slow-transit constipation and dyssynergic defecation.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","Vibrabot capsule","Main parameters of Vibrabot capsule: nominal diameter: 11.8±1mm; nominal length: 26.7±1mm; nominal weight: 4.5±1g.\n\nAfter the patient swallows the Vibrabot capsule, the capsule runs through the stomach → duodenum → jejunum and ileum → colon. According to the clinical data and configuration settings, the capsule will reach the colon and vibrate 8 hours after activation for ≥ 180 minutes in a cycle at low, medium, and high frequencies sequentially. The capsule relieves and treats constipation by massaging the colon wall through motor vibration to relieve colon muscle spasms and promote colonic peristalsis.\n\nThe VC well be taken between 21:00 and 22:00 every day, and the frequency of administration is determined based on the patient's individual situation.",[15,9,23,19],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Yangyang Qian","CONTACT","+86 13818040017","drfionachien@163.com",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Ji Xia","+86 15721570212","XiaJi0420@163.com",[43],{"facility":44,"status":10,"city":45,"state":10,"zip":10,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Changhai hospital","Shanghai","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":57,"phoneExt":10,"email":37},"Zhuan Liao, MD","86-21-31161004",{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[61,63,65,67,69,71,73],{"name":62,"class":6},"Ruijin Hospital",{"name":64,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine",{"name":66,"class":6},"Shanghai 10th People's Hospital",{"name":68,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":70,"class":6},"Shanghai 6th People's Hospital",{"name":72,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"name":74,"class":6},"Shanghai Pudong New Area Gongli Hospital","100547508","effect-of-vibration-capsule-on-different-subtypes-of-functional-constipation-100547508",false,"NCT06408883","Effect of Vibration Capsule on Different Subtypes of Functional Constipation","A Prospective Cohort Study On the Efficacy of Vibrating Capsule For Different Subtypes of Chronic Functional Constipation","Inclusion Criteria:\n\nPatients who can be diagnosed with functional constipation according to the Rome IV criteria.\n\nPatients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\nPeople who are not eligible for surgery or refuse to undergo any abdominal surgery; People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.\n\nPeople allergic to polymeric materials; People implanted with cardiac pacemakers and using gastrointestinal pacemakers; People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.\n\nPeople with dysphagia; Pregnant women; People with severe depression and anxiety and severe acute gastrointestinal lesions.\n\nPeople with other conditions, so the investigator considers them not eligible for this study.","ALL","18 Years",{"count":85,"type":86},600,"ESTIMATED","4 Weeks","OBSERVATIONAL","This study is a multi-center prospective cohort study, which plans to include 600 patients with chronic functional constipation to treat with Vibrabot capsules and patients will be grouped according to subtypes.\n\nDuring the study, the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication will be collected. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines.\n\nDuring the study, patients need to fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM).",[91,92],"Clinical Study","Chronic Functional Constipation",[94,95,92],"Vibrating Capsule","cohort study","NOT_YET_RECRUITING","2024-05-07",{"date":99,"type":100},"2024-05-10","ACTUAL",{"date":102,"type":86},"2024-06-01",{"date":104,"type":86},"2026-07-01",{"name":5,"class":6},1]