Clinical validation and commercialization of a novel hydrogel-based vaginal packing system for pelvic brachytherapy

This proposal aims to complete preclinical validation and commercialize a novel vaginal packing
product based upon a biocompatible polymer hydrogel strategy. The hydrogel will form in situ after
being injected into a bag placed within the vaginal cavity during pelvic brachytherapy. The hydrogel
packing can then be removed readily after the brachytherapy treatment. This Phase II proposal
focuses on preclinical validation of the hydrogel vaginal packing system in vaginal phantoms and
cadavers, proof of biocompatibility by an external lab, and clinical trials of vaginal packing during
cervical cancer brachytherapy. The hydrogel will serve as vaginal packing material during cervical
cancer brachytherapy, displacing rectum and bladder, providing attenuation and stabilizing the
applicator. Current alternatives include packing the vagina with gauze, which is uncomfortable for
patients, subject to errors and provides limited attenuation of radiation dose, and a commercially
available balloon system that is expensive and cumbersome to use. Our innovative polymer hydrogel
strategy will provide a simple, customized strategy for vaginal packing that provides attenuation and
consistent imaging properties while improving patient comfort and limiting costs. The small business
and academic partners will work together to test and commercialize the vaginal packing product for
clinical use.
The proposed research in phase II will focus on (Aim 1) validation of the hydrogel packing system’s
performance in phantoms designed to mimic vaginal cavities, on (Aim 2) evaluation of the
biocompatibility of the system and its performance as vaginal packing in soft-curved female cadavers,
and on (Aim 3) testing the product in a two-center clinical trial of cervical cancer brachytherapy in 40
human subjects. The phase II research program focuses on generating the evidence needed to
support a regulatory application and commercialization of the polymer hydrogel vaginal packing
product.Pelvic brachytherapy is a common treatment for women with gynecologic cancers, particularly
cervical cancer and endometrial cancer. Recent advances in image-guided treatment planning and
delivery have provided the capacity to deliver highly customized brachytherapy on an outpatient
basis, but limitations in the current options for vaginal packing methods present obstacles to the
delivery of optimal treatments. This project validates the preclinical performance and completes a
clinical trial in humans for a new, hydrogel-based vaginal packing product for clinical use during
image-guided brachytherapy. The product is based upon a novel self-expanding polymer hydrogel
technology that will improve the accuracy, conformality and patient comfort of pelvic brachytherapy.
The current proposal will lead to validation and commercialization of a new clinical product for pelvic
brachytherapy that will improve care for cervical cancer patients.