Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499521
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-08
First Post:
2020-07-22
Brief Title:
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
As part of vaginal brachytherapy the organs that do not need to receive radiation unrelated organs are moved out of the way of the radiation with a packing system The usual low cost and available standard of care packing systems to move these unrelated organs out of the way can sometimes be uncomfortable for the patient may not move all of the unrelated organs all the way out of the radiations path and rely on the doctor to place them correctly
If you participate you will receive 5 fractions of brachytherapy according to standard clinical care For three of the fractions a standard packing option will be used and for two of them BrachyGel VHPS will be used For the first fraction both groups will have the same packing option but participants will be randomized to either have BrachyGel during fractions 2 and 4 or during fractions 3 and 5 Youll be asked to complete a questionnaire after fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy from the packing system
If you participate you will receive 5 fractions of brachytherapy according to standard clinical care For three of the fractions a standard packing option will be used and for two of them BrachyGel VHPS will be used For the first fraction both groups will have the same packing option but participants will be randomized to either have BrachyGel during fractions 2 and 4 or during fractions 3 and 5 Youll be asked to complete a questionnaire after fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy from the packing system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None