Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-28 @ 5:21 PM
Study NCT ID:
NCT01837303
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2013-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
chemQbiosciences:Manual Liquid Based Cytology
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
chemQbiosciences:Manual Liquid Based Cytology
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.
Participants: 100-120 healthy women presenting for standard pap smear screening
Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.
Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.
Participants: 100-120 healthy women presenting for standard pap smear screening
Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.
Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.
Detailed Description:
Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.
Participants: 100-120 healthy women presenting for standard pap smear screening
Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.
Participants: 100-120 healthy women presenting for standard pap smear screening
Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.
Study Oversight
Has Oversight DMC:
False
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?: