BrachyGel VHPS for Uterine Cervical Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Uterine Cervical Neoplasms+1 More
BrachyGel VHPS - Device
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new, low cost packing system for brachytherapy to see if it is as effective as the standard options, and to understand any associated discomfort and safety concerns.

Eligible Conditions
  • Uterine Cervical Neoplasms
  • Cervical Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy

Week 2
Highest dose of radiation (in Gy) to the rectum and bladder for each patient
Week 4
Adverse Events
Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm B: BrachyGel in fractions 2 and 4
1 of 2
Arm A: BrachyGel in fractions 3 and 5
1 of 2

Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: BrachyGel VHPS · No Placebo Group · N/A

Arm B: BrachyGel in fractions 2 and 4
Device
Experimental Group · 1 Intervention: BrachyGel VHPS · Intervention Types: Device
Arm A: BrachyGel in fractions 3 and 5
Device
Experimental Group · 1 Intervention: BrachyGel VHPS · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: fractions/radiation treatments 2 - 5: about 1-4 weeks after starting brachytherapy

Who is running the clinical trial?

University of VirginiaLead Sponsor
679 Previous Clinical Trials
1,425,739 Total Patients Enrolled
2 Trials studying Uterine Cervical Neoplasms
63 Patients Enrolled for Uterine Cervical Neoplasms
BrachyFoam, LLCUNKNOWN
Kara RomanoPrincipal Investigator - University of Virginia
University of Virginia

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.
You have a biopsy showing cancer of the cervix.
You are planning to receive brachytherapy as a part of the definitive treatment for cervical cancer.
You have a KPS ≥ 70 or ECOG status ≤ 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.