Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432478
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-11
Brief Title:
3D Printed Custom Applicators for HDR BT DISCO
Sponsor:
Royal North Shore Hospital
Organization:
Royal North Shore Hospital
Study Overview
Official Title:
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy DISCO
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators
Detailed Description:
Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions Current workflows for designing and constructing custom applicators with wax moulds are complex time consuming and can result in a device that fails to meet original design specifications dictated by the planning system In contrast 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labourequipment costs and ensures a more robust product for treatment Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None