[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05451563":3,"trial-entities:NCT05451563":75,"trial-summary:NCT05451563":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":13,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":50,"locations":53,"central_contacts":63,"overall_officials":69,"references":73,"see_also_links":74},"NCT05451563","65457","Double-S: a Wearable Device for Erectile Dysfunction","RECRUITING","2026-06","2025-05","2025-05-22","2024-03-21","Stanford University","OTHER",false,"The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.","The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse.\n\nThe goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.",[18],"Erectile Dysfunction",[],"INTERVENTIONAL",[22],"NA",{"count":24,"type":25},10,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Double-S","Wearable device for intercourse",[32],"Double-S arm",[34],{"measure":35,"description":36,"timeFrame":37},"Change in modified International Index of Erectile Dysfunction score","score 0 to 30 with higher score meaning better erectile function","baseline and up to 1 month post-baseline",[],"MALE","18 Years",null,{"inclusion":43,"exclusion":46,"raw_text":49},[44,45],"males \\>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and\u002For radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and\u002For metabolic ED etc.)","having a female partner willing to participate in the study",[47,48],"not willing to attempt sexual vaginal intercourse with their partner","inability to wear\u002Foperate the external penile device for any reason","Inclusion Criteria:\n\n* males \\>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and\u002For radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and\u002For metabolic ED etc.)\n* having a female partner willing to participate in the study\n\nExclusion Criteria:\n\n* not willing to attempt sexual vaginal intercourse with their partner\n* inability to wear\u002Foperate the external penile device for any reason",[51,52],"ADULT","OLDER_ADULT",[54],{"facility":55,"status":7,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Stanford Healthcare, Stanford Hospital","Stanford","California","94304","United States",{"lat":61,"lon":62},37.42411,-122.16608,[64],{"name":65,"role":66,"phone":67,"email":68},"Satvir Basran","CONTACT","650-723-0948","sbasran@stanford.edu",[70],{"name":71,"affiliation":12,"role":72},"Michael Eisenberg, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":76,"biomarkers":77},[18],[],{"nct_id":4,"found":79,"summary":80,"prompt_version":90},true,{"design":81,"status":82,"heading":83,"summary":84,"follow_up":85,"word_count":86,"commitments":87,"compensation":88,"drugs_mentioned":89},"This study is testing a device called Double-S in about 10 male participants.","completed","Study of the Double-S Wearable Device for Erectile Dysfunction","This study is testing a wearable device called Double-S for men who experience erectile dysfunction (ED). This includes men with ED from various causes, such as after prostate cancer treatment, or due to vascular or metabolic issues. The goal is to see if the Double-S device can help you achieve satisfactory erections for intercourse without medication. The study will measure success by looking at changes in your International Index of Erectile Dysfunction score, which is a questionnaire about erectile function. This study is currently recruiting about 10 male participants who are over 18 years old.","Your erectile function will be assessed at the start of the study and up to 1 month after you begin using the device.",95,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]