Recruiting
Phase 1

Barrigel

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07292818

Conditions

Cervix Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Barrigel gel spacer

Study Details

Brief 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

Study ID

NCT07292818

Start date

Feb 2, 2026

Status verified date

Feb, 2026

Completion date

Oct 30, 2030

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Subject is willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at time of consent.
  • Eastern Cooperative Oncology Group Performance Status of 0-2 or Karnofsky Performance Scale score of 50-100.
  • Histological or cytological evidence of cervical cancer. Only patients with cervical cancer who are planned for chemoradiotherapy with brachytherapy, except for individuals with known rectal invasion.

Exclusion Criteria:

  • Active infection requiring systemic therapy.
  • Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study).
  • Known allergy to hyaluronic acid-based products.
  • Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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 ]
  • Safety based on Patient Reported Outcome Report based on The Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment [ Time Frame: Up to 3 months after completion of radiotherapy ]
  • Safety based on Patient Reported Outcome Report based on Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: Up to 3 months after completion of radiotherapy ]
  • Distance between uterus/cervix/proximal vagina and rectum [ Time Frame: Up to 7 weeks (at the end of radiotherapy) ]
  • Gel placement procedure time [ Time Frame: Up to 7 weeks (at the end of radiotherapy) ]
  • Difficulty of gel placement [ Time Frame: Up to 7 weeks (at the end of radiotherapy) ]

Central Contacts and Locations

Central contacts

Melissa Knutsen

919-966-4432Melissa_Knutsen@med.unc.edu

Locations

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Melissa Knutsen

919-918-5924Melissa_Knutsen@med.unc.edu

Principal Investigator:

Shivani Sud, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • radiotherapy
  • brachytherapy
  • gel spacer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-02-04.