Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593106
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Cryodevitalization for the Treatment of Early Stage Lung Cancer CRYSTAL Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The CRYSTAL Study Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage stage I or stage II lung cancer Cryodevitalization is a type of cryosurgery that uses a flexible probe cryoprobe to kill tumor cells by freezing them It is delivered at the time of standard diagnostic robotic bronchoscopy Using cryodevitalization may be safe tolerable andor effective in treating patients with early stage lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To identify the maximum tolerated dose MTD for cryodevitalization cycle duration
OUTLINE This is a dose-escalation study
Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3 5 or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study Patients then undergo standard of care surgical resection on study Patients also undergo a chest radiography x-ray on study as well as computed tomography CT and tissue sample collection throughout the study
After completion of study treatment patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months
I To identify the maximum tolerated dose MTD for cryodevitalization cycle duration
OUTLINE This is a dose-escalation study
Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3 5 or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study Patients then undergo standard of care surgical resection on study Patients also undergo a chest radiography x-ray on study as well as computed tomography CT and tissue sample collection throughout the study
After completion of study treatment patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None