[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hyivy Health Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100488670","hyivy-device-as-non-hormonal-therapy-in-endometriosis-100488670",false,"NCT05643131","Hyivy Device as Non-hormonal Therapy in Endometriosis","Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis","Inclusion Criteria:\n\n* 1.Age ≥ 18 at the time of enrollment\n* 2.Generally in good health (other than due to endometriosis), at physician's discretion\n* 3.Diagnosed with endometriosis (clinical, radiologic, or surgical)\n* 4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting \\>3 months)\n* 5.VAS for overall pelvic pain ≥ 4 at screening and baseline\n* 6.Medically managing endometriosis using continuous hormonal medications (i.e., oral contraceptive pills, progesterone only pills, Mirena, GnRH agonists\u002Fantagonists) for at least 3 months prior to enrollment\n* 7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period, including hormonal therapies for any medical condition, and complimentary and\u002For alternative management of surgery for endometriosis and associated chronic pain\n* 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study\n* 9.Agrees to avoid taking non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for 72 hours before Visits 1, 2, and 3\n* 10.Must have the ability to charge the investigational device\n* 11.Must be willing and able to insert intravaginal device\n* 12.Able to understand, comply and consent to protocol requirements and instructions\n* 13.Able to attend scheduled study visits and complete required investigations\n\nExclusion Criteria:\n\n* 1.Chronic pelvic pain thought to be due to a condition other than endometriosis\n* 2.Diagnosis of premature ovarian insufficiency\n* 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)\n* 4.Any surgery in the past 3 months or anticipates having surgery during the study\n* 5.Allergy to Hyivy device's materials\n* 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) or infection in the pelvic area\n* 7.Current use of antibiotics and a history of vulvovaginal candidiasis\n* 8.Pregnant or lactating\n* 9.Currently under the care of a pelvic floor physiotherapist\n* 10.Have open wounds, cuts, or open sores present in vaginal or pelvic area\n* 11.Severe atrophic vaginitis or very dry, itchy, or sore vagina\u002Fvaginal area, at the discretion of the primary investigator(s)\n* 12.Hypoesthesia or loss in sensation of the pelvic floor\n* 13.Total and\u002For partial prolapse of the uterus and\u002For vagina\n* 14.Symptoms of severe urinary retention, severe extra-urethral incontinence or overflow incontinence\n* 15.Unable to position the device according to directions for use\n* 16.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants","FEMALE","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study seeks to address accessible management of endometriosis-associated chronic pelvic pain by evaluating a novel device used in the home. The study is designed as a proof-of-concept single-arm pilot study, and the primary objective is to assess change in overall self-reported pelvic pain in people with endometriosis-associated chronic pelvic pain following the use of the Hyivy intravaginal device.",[26,27],"Endometriosis","Pelvic Pain",[26,27,29],"Dilator","NOT_YET_RECRUITING","2025-09-11",{"date":33,"type":34},"2025-09-17","ACTUAL",{"date":36,"type":20},"2025-10",{"date":38,"type":20},"2026-12",{"name":40,"class":41},"Hyivy Health Inc","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"100489064","feasibility-of-hyivy-device-post-radiation-for-pelvic-malignancies-100489064","NCT05648253","Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies","Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies","Inclusion Criteria:\n\n* 1.Age ≥ 18 at the time of enrollment\n* 2.Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy\n* 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)\n* 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2\n* 5.Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and\u002For uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.\n* 6.Agree not to use other dilators for the 12-week intervention period\n* 7.Must have the ability to charge the investigational device\n* 8.Must be willing and able to insert intravaginal device\n* 9.Able to understand, comply and consent to protocol requirements and instructions\n* 10.Able to attend scheduled study visits and complete required investigations\n* 11.Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* 1.Participants who are pregnant or planning to become pregnant during the trial\n* 2.Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study\n* 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)\n* 4.Allergy to Hyivy device's materials\n* 5.Active pelvic or gynaecological infection\n* 6.Current use of antibiotics for any infection\n* 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area\n* 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina\u002Fvaginal area, at the discretion of the investigator(s)\n* 9.Hypoesthesia or loss in sensation of the pelvic floor\n* 10.Total and\u002For partial prolapse of the uterus and\u002For vagina\n* 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence\n* 12.Unable to position the device according to directions for use\n* 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants",{"count":51,"type":20},12,[23],"Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.",[55,56,57,27,58],"Vaginal Stenosis","Radiation Therapy","Cancer","Pelvic Cancer",[29,60],"Post radiation therapy","RECRUITING","2025-04-17",{"date":64,"type":34},"2025-04-22",{"date":66,"type":34},"2025-04-11",{"date":68,"type":20},"2026-06",{"name":40,"class":41},""]