Actively Recruiting
Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-02-04
14
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
T
Teleflex
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Willing and able to follow study procedures as judged by the investigator
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group Performance Status of 0-2 or Karnofsky Performance Scale score of 50-100
- Histological or cytological confirmation of cervical cancer
- Planned to receive chemoradiotherapy with brachytherapy, excluding those with known rectal invasion
You will not qualify if you...
- Active infection requiring systemic therapy
- Pregnant or breastfeeding (breast milk cannot be stored during treatment)
- Known allergy to hyaluronic acid-based products
- Known inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
M
Melissa Knutsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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