NCT07292818RecruitingPhase 1
Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
Feasibility Study of Novel Applications of Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 2 Feb 2026
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Cervical cancer
- NCT number
- NCT07292818
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 14
- From 2 Feb 2026 to the primary completion date, 30 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active infection requiring systemic therapy.
- Known allergy to hyaluronic acid-based products.
- Known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
Other
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated in the study).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.