Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

This pilot feasibility study evaluates the use of a hyaluronic acid-based spacing gel (Barrigel) in participants with cervical cancer undergoing chemoradiotherapy (chemoRT), including brachytherapy, as part of standard care. The primary goal is to assess feasibility. Other goals include determining whether gel placement can reduce radiation dose to nearby healthy organs (organs at risk, OAR) and improve delivery of the prescribed radiation dose to the tumor. In cervical cancer, the radiation dose to the tumor is often limited by the risk of exposing nearby sensitive organs, such as the rectum, bladder, and other pelvic structures. Vaginal packing techniques and specialized devices are used to protect these organs and ensure effective treatment. Gel spacers are inserted before radiation therapy to create space between the rectum and the cervix, reducing radiation exposure to healthy tissue. Already widely used in prostate cancer treatment in the U.S., gel spacers may also help improve tumor control and reduce treatment-related toxicity in cervical cancer.

NCT Number	NCT07292818
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: Teleflex
Conditions	Cervix Cancer
Enrollment	14 participants
Start Date	2026-02-02
Primary Completion	2027-10-30 (estimated)
Study Completion	2030-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-04