[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651594":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ED Patient Group",null,"Males aged 18-70 years diagnosed with erectile dysfunction (ED) for more than 6 months, with an IIEF-5 score of less than 21.",[13,14],"Device: Intelligent Flexible Penile Monitoring System","Device: RigiScan Plus",{"label":16,"type":10,"description":17,"interventionNames":18},"Healthy Volunteer Group","Healthy male volunteers aged 18-70 years with normal erectile function and an IIEF-5 score of 21 or greater.",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Intelligent Flexible Penile Monitoring System","A novel, ultra-thin (\\\u003C0.8mm) flexible sensing system used for prospective monitoring of penile rigidity and tumescence during sleep.",[9,16],{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":10},"RigiScan Plus",[9,16],[29],{"name":30,"affiliation":5,"role":31},"Bin Xu","STUDY_CHAIR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Chao Sun","CONTACT","+86 13813966939","fertility@126.com",[39],{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Zhongda Hospital Southeast University","Nanjing","Jiangsu","210009","China","CN",{"type":47,"coordinates":48},"Point",[49,50],118.77778,32.06167,{"lat":50,"lon":49},[53],{"name":34,"role":35,"phone":54,"phoneExt":10,"email":37},"+86-13813966939",{"type":56,"investigatorFullName":30,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Chief Physician","100651594","diagnostic-performance-of-a-flexible-penile-monitoring-system-for-ed-100651594",false,"NCT07762469","Diagnostic Performance of a Flexible Penile Monitoring System for ED","Diagnostic Performance Evaluation and Clinical Translation Research of a New Intelligent Flexible Penile Monitoring System for Erectile Dysfunction","Inclusion Criteria:\n\n1. Males aged 18-70 years with good communication and compliance.\n2. Able to follow clinical Standard Operating Procedures (SOPs) and complete two-stage nocturnal monitoring and clinic-induced tests.\n3. Fully informed about the study and signed the informed consent form.\n4. For ED Group: Clinically diagnosed with erectile dysfunction with an IIEF-5 score \\\u003C 21.\n5. For Healthy Group: Normal erectile function, no history of related physiological diseases or sexual psychological disorders, with an IIEF-5 score ≥ 21.\n\nExclusion Criteria:\n\n1. Systemic diseases: Severe cardiovascular disease (e.g., recent myocardial infarction, unstable angina), uncontrolled severe diabetes, or severe obstructive sleep apnea syndrome.\n2. Local anatomical factors: Severe penile malformation, spinal cord injury, or organic structural damage caused by pelvic fracture; or major surgery within the last six months.\n3. Skin and allergy factors: Active infection or eczema in the penile area, or known allergy to flexible materials (medical-grade silicone\u002Fadhesives).\n4. Mental and psychological factors: Untreated or unstable severe depression, anxiety, or other mental disorders.\n5. Medication interference: Current use of PDE5 inhibitors, androgens, anti-androgens, or drugs that significantly interfere with REM sleep structure.\n6. Other factors: Currently participating in other interventional clinical trials, or judged by researchers to have poor compliance.",true,"MALE","18 Years","70 Years",{"count":70,"type":71},60,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the diagnostic performance of a novel intelligent flexible penile monitoring system for erectile dysfunction (ED). The current gold standard, RigiScan Plus, often causes discomfort and disrupts sleep due to its mechanical rings, leading to potential \"first-night effect\" biases. This research utilizes a prospective crossover design to compare the accuracy of the new flexible system with RigiScan in measuring peak rigidity and tumescence. A total of 60 participants (30 ED patients and 30 healthy volunteers) will be enrolled. The study expects to confirm that the flexible system provides highly accurate diagnostic data while significantly improving patient comfort and maintaining natural sleep structures.",[75],"Erectile Dysfunction",[77,78,79,80,81],"Nocturnal Penile Tumescence","Flexible Sensor","Wearable Device","RigiScan","Diagnostic Performance","NOT_YET_RECRUITING","2026-08-08",{"date":85,"type":86},"2026-08-13","ACTUAL",{"date":88,"type":71},"2026-08-01",{"date":90,"type":71},"2028-02-01",{"name":30,"class":6},1]