Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

NCT07292818 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: LCCC2310
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

radiotherapy; brachytherapy; gel spacer

Outcome Measures

Primary Outcomes (6)

• Safety based on Grade 3 or higher adverse events associated with hyaluronic acid-based rectal spacer placement

  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.

  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

  Patient assessments of symptom characteristics will be surveyed based on the Patient Reported Outcome Report, based on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment. Each item in the EPIC bowel domain uses a 5-point Likert scale. The responses are numerically coded and then converted to a 0-100 scale, where higher scores = better function / less bother. No problem=1, very small problem =2, small problem=3, moderate problem=4, big problem=5

  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)

  The PRO-CTCAE survey, focused on gastrointestinal and genitourinary symptoms, will be used assessment of toxicity. The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities reported from the patient perspective. PRO-CTCAE uses 5-point Likert scales to assess the frequency, severity, and daily life interference of patient-reported symptoms, with higher scores indicating more frequent, severe, or bothersome experiences.

  Up to 3 months after completion of radiotherapy

• Distance between uterus/cervix/proximal vagina and rectum

  The distance between the uterus, cervix, proximal vagina, and rectum will be measured using images acquired during brachytherapy.

  Up to 7 weeks (at the end of radiotherapy)

• Gel placement procedure time

  Time required to complete gel placement will be reported.

  Up to 7 weeks (at the end of radiotherapy)

• Difficulty of gel placement

  Difficulty of Barrigel Procedure Insertion will be graded based on provider response to a 4-point scale survey. Higher scores represent difficult insertions. 1- Very Easy: All anatomical landmarks were easy to spot on transrectal ultrasonogram (TRUS), and Barrigel was well-visualized during injection. The tissue is separated well with Barrigel. Visible spacing between the cervix and rectum was achieved. The implant was positioned well and sculpted to the desired (symmetric) shape. 2- Easy: Most landmarks were easily seen, Barrigel was well-visualized, tissue separated reasonably well overall, although the shape may not be ideal. 3- Difficult: Some anatomy or Barrigel was difficult to visualize on TRUS, and/or the tissue didn't separate well in places with Barrigel. Spacing goals were notably not achieved, but some useful space was provided. 4- Very Difficult: The TRUS visibility was compromised, and/or the gel didn't get injected as planned due to tissue.

  Up to 7 weeks (at the end of radiotherapy)

Secondary Outcomes (1)

• Implant geometry

  Up to 7 weeks (at the end of radiotherapy)

Study Arms (1)

Brachytherapy with hyaluronic acid-based gel spacer

EXPERIMENTAL

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.

Device: Barrigel gel spacer

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.

Also known as: Hyaluronic acid- based rectal spacer

Brachytherapy with hyaluronic acid-based gel spacer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cervical carcinoma is seen only in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Teleflex: collaborator

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shivani Sud, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Knutsen

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)