Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07292818
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cervix Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Barrigel gel spacer — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2030

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Brachytherapy with hyaluronic acid-based gel spacer
    Patients with cervical cancer who are scheduled to undergo definitive chemoradiotherapy, including brachytherapy, with the use of hyaluronic acid-based gel spacer to increase the distance between the cervix and the anterior rectal wall.

Primary Outcome Measure

Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement [ Time Frame: Up to 3 months after completion of radiotherapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel HillChapel HillNorth Carolina27599
Melissa Knutsen
[email protected]
919-918-5924
Shivani Sud, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By research site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill· Chapel Hill, NC

Related Studies