[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597955":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":22,"interventions":35,"overallOfficials":47,"centralContacts":52,"locations":58,"responsibleParty":76,"collaborators":13,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":13,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":61,"whyStopped":13,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Erbe Elektromedizin GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Concentration of AMH (Anti-Müller hormone) level","The comparison of patient AMH changes (ΔAMH) before and after surgery (Follow up Visit after 3 and 6 months) with either APC or standard cystectomy (ΔAMH Group 1 versus ΔAMH Group 2).","Screening Visit 1 (up to -28 days before day 0); Visit 3 (day 0 +3 months +\u002F- 14 days; Visit 4 (day 0 + 6 months +\u002F- 14 days)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"SINGLE",[21],"PARTICIPANT",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Standard cystectomy","OTHER","Investigator uses lap bipolar forceps for endometrioma treatment (standard treatment)",[28],"Device: Lap bipolar forceps",{"label":30,"type":31,"description":32,"interventionNames":33},"APC treatment","EXPERIMENTAL","Investigator uses APC applicator for endometrioma treatment. This is a CE approved device",[34],"Device: APC",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","APC","For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used",[30],[42],"APC Treatment with APCapplicator",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":13},"Lap bipolar forceps","For ovarian endometrioma treatment the standard of care treatment will be performed.",[24],[48],{"name":49,"affiliation":50,"role":51},"Bernhard Krämer, Prof. Dr. med.","Department for Women's Health, Tuebingen, Germany","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":13,"email":57},"Vanessa Steinmetz","CONTACT","+49 70717552850","vanessa.steinmetz@erbe-med.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":63,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department for Women's Health","RECRUITING","Tübingen","Germany","72076","DE",{"type":67,"coordinates":68},"Point",[69,70],9.05222,48.52266,{"lat":70,"lon":69},[73],{"name":49,"role":55,"phone":74,"phoneExt":13,"email":75},"+49 7071 29 82211","bernhard.kraemer@med.uni-tuebingen.de",{"type":77,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100597955","argon-plasma-treatment-for-ovarian-endometrioma-compared-to-standard-cystectomy-100597955",false,"NCT07065214","Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy","Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study","OVAPLAS","Inclusion Criteria:\n\n* Indication for surgical endometrioma treatment according to patient symptoms\n* Signed informed consent\n\nExclusion Criteria:\n\n* Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial\n* Prior procedures at the ovaries\n* Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)\n* Pregnant or breastfeeding patients\n* Participation in any other clinical study that could affect the AMH level or pregnancy","FEMALE","18 Years","40 Years",{"count":90,"type":91},72,"ESTIMATED","INTERVENTIONAL",[94],"NA","The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany.\n\nIn this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment.\n\nSeventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization.\n\nA pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint.\n\nScreening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.",[97],"Endometriosis",[99],"ovarian endometriosis","2026-10-06",{"date":102,"type":103},"2026-10-07","ACTUAL",{"date":105,"type":103},"2025-11-26",{"date":107,"type":91},"2029-05-30",{"name":5,"class":6},1]