[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599244":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":11},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group: 40 women will receive the active Bioheat patch.","EXPERIMENTAL",null,[13],"Other: Bioheat Patch",{"label":15,"type":10,"description":11,"interventionNames":16},"Control Group: 40 women will receive a non-heating placebo patch",[17],"Other: Placebo Patch",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"OTHER","Bioheat Patch","Bioheat Patch for pain relif",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo Patch","placebo Patch",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Prof. Yaakov Melcer Prof. Yaakov Melcer Principal Investigator shamir Medical, MD","CONTACT","+972547781821","ymeltcer@gmail.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Yaakov Melcer","Professor yaakov melcer","100599244","effect-of-the-bioheat-patch-on-pain-following-the-hyfosy-procedure-100599244",false,"NCT07081971","Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure","B-HyP","Inclusion Criteria:\n\nWomen aged 18-45 scheduled for HyFoSy\n\nNo dermatologic conditions at the patch site\n\nNo allergies to patch ingredients, or heat\n\nNo active pelvic infections\n\nExclusion Criteria:\n\nActive genital infection\n\nSkin issues in lower abdomen\n\nSensitivity to heat\n\nAny medical condition preventing local heat use",true,"FEMALE","18 Years","45 Years",{"count":50,"type":51},80,"ESTIMATED","INTERVENTIONAL",[54],"NA","This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy).\n\nHyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility workup. While generally less painful than HSG, many patients still report moderate to severe cramping and discomfort during and after the test.\n\nThermal therapy has demonstrated effectiveness in reducing musculoskeletal and gynecological pain. Bioheat patches, approved by the Israeli Ministry of Health for menstrual pain relief, emit safe, low-grade heat (approximately 37-38°C) and may provide a non-invasive pain management strategy post-HyFoSy.\n\nParticipants (n=80) will be women aged 20-45 undergoing HyFoSy. They will be randomly assigned to either the Bioheat intervention group or a placebo patch group, applied externally to the lower abdomen. The heat-producing patch contains iron and other safe materials that react with oxygen to emit continuous heat without electricity. Infrared radiation from the patch components may also promote local vasodilation and muscle relaxation.\n\nPain assessment will use the validated Visual Analog Scale (VAS), collected post-procedure via follow-up SMS and phone contact. The study aims to quantify reduction in perceived pain, and potentially improve patient satisfaction with HyFoSy. Safety has been pre-established, with no reported adverse skin effects when used as instructed.\n\nStudy duration is six months, following ethics approval at the OB-GYN ultrasound department of Shamir Medical Center.",[57,58,59,60],"Pelvic Pain","Infertility","Pain Management","Gynecologic Procedures","NOT_YET_RECRUITING","2025-07-28",{"date":64,"type":65},"2025-07-30","ACTUAL",{"date":67,"type":51},"2025-08-01",{"date":69,"type":51},"2025-12-30",{"name":5,"class":6}]