NCT07292818

Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Feasibility Study of Novel Applications of Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervix Cancer

Interventions

Type	Name	Description
DEVICE	Barrigel gel spacer	Barrigel (Hyaluronic acid- based gel spacer) will be used to increase the distance between the cervix and the anterior rectal wall, with the intent to decrease the radiation dose delivered to the rectum.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-10-30
• Completion: 2030-10-30
• First posted: 2025-12-18
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study