RecruitingPhase 1NCT07292818

Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

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


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

14 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether placing a hyaluronic acid-based gel spacer between the cervix and the rectum before radiation therapy can protect the rectum from radiation damage in women receiving treatment for cervical cancer. **You may be eligible if...** - You are 18 or older - You have cervical cancer confirmed by biopsy or cell testing - Your treatment plan includes chemoradiotherapy followed by internal radiation (brachytherapy) - You do not have rectal involvement (spread to the rectum) by your cancer - You are in adequate health (ECOG 0–2 or equivalent) **You may NOT be eligible if...** - You have an active infection requiring systemic antibiotics - You are pregnant or breastfeeding - Rectal invasion by your cancer is confirmed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBarrigel 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.


Locations(1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

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NCT07292818


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