Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Barrigel gel spacer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brachytherapy with hyaluronic acid-based gel spacer
- description
- 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.
- interventionNames
- Device: Barrigel gel spacer
Primary outcomes (6)
- measure
- Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement
- timeFrame
- Up to 3 months after completion of radiotherapy
- description
- The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. Number of participants with Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement will be presented.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available