NCT04499521Completed
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
A Randomized, Non-Inferiority Study of a Hydrogel Packing System Compared to Standard of Care Packing During Image-Guided High-Dose Rate Brachytherapy Boost for Cervical Cancer
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
In this study, a new, low cost packing system ("BrachyGel VHPS") is being tested as a packing option during brachytherapy along with standard options to make sure that it keeps the unrelated organs away from radiation at least as well as the standard options, and to better understand the safety and patient discomfort associated with BrachyGel VHPS and the standard packing options.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 22 Jul 2020
- Start date
- 17 Mar 2021
- Primary completion date
- 9 Dec 2022
- Lead sponsor
- University of Virginia
- Diseases
- Cervical cancer
- NCT number
- NCT04499521
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 17 Mar 2021 to the primary completion date, 9 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known pregnancy or lactation (no pregnancy test required prior to participation)
Other illness
- History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest"
- History of total or partial hysterectomy
- Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest
Other
- Known contraindications to brachytherapy
Who the study is looking for
- Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc)
- FIGO IB1 - IVB Staging according to FIGO and TNM guidelines
- Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer
- Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years
- Agreement to adhere to Lifestyle Considerations throughout study duration
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.