Spots Global Cancer Trial Database for Hyivy Device in Post-radiation Patients

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Trial Identification

Brief Title: Hyivy Device in Post-radiation Patients

Official Title: Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies

Study ID: NCT05648253

Conditions

Vaginal Stenosis

Radiation Therapy

Cancer

Interventions

Vaginal Dilator Therapy by Hyivy device

Study Description

Brief 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

Detailed Description: Prior to study enrollment, all prospective participants will have the ability to contact the study team to learn more about the study and be provided with the relevant study-specific information. After being informed about the study and potential risks, all participants giving written informed consent will be assessed for their eligibility for the study, and enrolled participants will undergo a maximum 30-day screening period. On Day 0, eligible participants will start a 12-week use of Hyivy device with one visit on Week 6-7 and another on Week 12. After completing the 12-week intervention period, a virtual follow-up will be conducted on Week 16.