[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566523":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":31,"overallOfficials":16,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":16,"id":65,"slug":16,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":16,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":16,"enrollmentInfo":73,"targetDuration":16,"studyType":76,"phases":77,"briefSummary":78,"conditions":79,"keywords":16,"overallStatus":82,"whyStopped":16,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"HaEmek Medical Center, Israel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.","When the uterus will be opened the suture will be observed.","Immediately after the procedure.",[14],{"measure":15,"description":16,"timeFrame":12},"Safety: Procedure complications - Uterine perforation, vaginal\\cervical\\uterine injury.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","Introduction:\n\nA hysteroscopy is a procedure used to examine and treat the inside of the uterus.\n\nApollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy.\n\nThe aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope.\n\nStudy Design Interventional pilot study\n\nStudy group:\n\nWomen undergoing laparoscopic hysterectomy.\n\nInclusion criteria:\n\nBenign indication for hysterectomy\n\nExclusion from the study:\n\nEvidence or suspicious for malignancy\n\nSample size calculation:\n\nPilot study of 2 patients.\n\nPrimary outcome:\n\nIntrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed.\n\nSecondary outcome:\n\nProcedure complications.\n\nRecruitment:\n\nThe recruitment of the patients will be done at the gynecology department before the surgery.\n\nProcedure:\n\nAfter general anesthesia and entering the abdomen with the laparoscope, Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity. Insertion of normal saline to the cavity and applying 4 points suturing to the uterus. The procedure will be monitored by external laparoscopic camera located in the abdominal cavity. After the hysterectomy the uterus will be opened and the suture will be examine.\n\nA preoperative intrauterine incision using a hysteroscope, followed by suturing, will be considered based on the success of the first procedure.\n\nCRF:\n\nDemographics information, obstetrics and gynecology information, surgery type, surgery indication.\n\nProcedure duration, success, amount of fluid used, cervical dilatation, complications.",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"Women undergoing laparoscopic hysterectomy","EXPERIMENTAL","Women undergoing laparoscopic hysterectomy for benign indication with no evidence or suspicious for malignancy.",[30],"Device: Intra-Uterine suturing by X-TACK device and hysteroscope",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":16},"DEVICE","Intra-Uterine suturing by X-TACK device and hysteroscope","After general anesthesia and entering the abdomen with the laparoscope, Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity. Insertion of normal saline to the cavity and applying 4 points suturing to the uterus. The procedure will be monitored by external laparoscopic camera located in the abdominal cavity. After the hysterectomy the uterus will be opened and the suture will be examine.\n\nA preoperative intrauterine incision using a hysteroscope, followed by suturing, will be considered based on the success of the first procedure.",[26],[38],{"name":39,"role":40,"phone":41,"phoneExt":16,"email":42},"Adi Dayan Schwartz, MD","CONTACT","+972-4-6494331","adi.schwartz1@mail.huji.ac.il",[44],{"facility":45,"status":16,"city":46,"state":16,"zip":16,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Emek Medical Center","Afula","Israel","IL",{"type":50,"coordinates":51},"Point",[52,53],35.2892,32.60907,{"lat":53,"lon":52},[56,60],{"name":57,"role":40,"phone":58,"phoneExt":16,"email":59},"Snait Ayalon","0097246494264","snait_ay@clalit.org.il",{"name":61,"role":62,"phone":16,"phoneExt":16,"email":16},"Adi Dayan-Schwartz, MD","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100566523",false,"NCT06656286","Hysteroscopic Intrauterine Suturing","Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study","Inclusion Criteria:\n\n* Benign indication for hysterectomy\n\nExclusion Criteria:\n\n* Evidence or suspicious for malignancy","FEMALE","18 Years",{"count":74,"type":75},2,"ESTIMATED","INTERVENTIONAL",[18],"Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack, inserted into the uterus by hysteroscope.\n\nPrimary outcome:\n\nIntrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed.\n\nSecondary outcome:\n\nProcedure complications. Study Design Interventional pilot Study\n\nStudy group:\n\nWomen undergoing laparoscopic hysterectomy.",[80,81],"Niche","Uterine Disease","NOT_YET_RECRUITING","2025-03-12",{"date":85,"type":86},"2025-03-13","ACTUAL",{"date":88,"type":75},"2025-04-25",{"date":90,"type":75},"2026-07-02",{"name":5,"class":6},1]