Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix

Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-up Screening

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00266084

Enrollment

Registered

2005-12-15

Start date

1999-08-31

Completion date

2001-11-30

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Cancer, Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia

Keywords

Cervix, Uterus, Dysplasia, Cancer, Collector

Brief summary

This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely

Detailed description

This study tested the feasibility, safety and efficacy of the new e2TM Collector, and compared its performance with the standard method for obtaining cervical cells for Pap test of endocervical cytobrush and Ayer's Spatula

Interventions

None listed

Eligibility

Sex/Gender

FEMALE

Age

14 Years to No maximum

Healthy volunteers

Inclusion criteria

Women ages \>14 being followed for a previous abnormal Pap All patients will have signed an Informed Consent form prior to being enrolled in this study

Exclusion criteria

Patients who have had a hysterectomy

Outcome results