Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464107
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-06
Brief Title:
Endometrial Cell Collection With the PadKit
Sponsor:
Hackensack Meridian Health
Organization:
Hackensack Meridian Health
Study Overview
Official Title:
Endometrial Cancer Cell Collection With the Preprogen PadKit
Status:
RECRUITING
Status Verified Date:
2024-06
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:
All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium After the kit is returned to the Preprogen laboratory a brief survey will be completed Analysis will be conducted to determine if the PadKit can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasiamalignant cells in blinded samples provided to the laboratory for analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None