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Not Yet Recruiting NCT05648253

Hyivy Device in Post-radiation Patients

Conditions: Vaginal Stenosis, Radiation Therapy, Cancer

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 12
Sponsor: Hyivy Health Inc

Summary

The objective of this study is to evaluate the feasibility of using the Hyivy device as a non-hormonal therapy in post-radiation patients with pelvic malignancies

Eligibility Criteria

Inclusion Criteria:1.Age ≥ 18 at the time of enrollment2.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 at least 2 weeks prior to starting the intervention, without concomitant chemotherapy3.The participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening. Or, a participant of child-bearing potential must have a negative baseline urine pregnancy test and 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 months4.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period5.Must have the ability to charge the investigational device6.Must be willing and able to insert intravaginal device7.Able to understand, comply and consent to protocol requirements and instructions8.Able to attend scheduled study visits and complete required investigations9.Eastern Cooperative Oncology Group (ECOG) of 0 to 210.Ability to understand and willingness to sign written informed consent11.Healthy as determined by laboratory results, medical history, and physical exam as assessed by qualified investigatorExclusion Criteria:1.Participants who are pregnant or planning to become pregnant during the trial2.Diagnosis of premature ovarian insufficiency3.Has a condition rendering them unable to understand the nature, scope and possible consequences of the study, or evidence of an uncooperative attitude4.Any major surgery in the past 3 months or anticipates having a major surgery during the study5.Allergy to Hyivy device's materials (silicone, plastic, and/or metals)6.Active vaginal infection (e.g., vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, sexual transmitted infections) Current use of antibiotics and a history of vulvovaginal candidiasis

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05648253). StuddyBuddy aggregates publicly available trial information.