Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2030-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervix Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Barrigel gel spacer

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Hyaluronic acid- based rectal spacer

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No