Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.

CytoCore, Inc.737 enrolled

Overview

A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer. The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector

The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.

Study Type

OBSERVATIONAL

Enrollment

737

Conditions

Colposcopy Biopsy

Interventions

e2 Cell Collector [SoftPAP(R)]DEVICE

Cervical cells collected using the e2 Cell Collector \[SoftPAP(R)\]

Spatula/BrushDEVICE

Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women ages 18 years old and above * Women scheduled to undergo colposcopy Exclusion Criteria: * Patients who have had a hysterectomy * Patients who are pregnant.

Locations (7)

Visions Clinical Research

Wellington, Florida, United States

Comprehensive Clinical Trials

West Palm Beach, Florida, United States

St. Louis University

St Louis, Missouri, United States

University of Cincinnati

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Cell Collection Efficacy

True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.

Time frame: At the time of cell collection.

Specimen Adequacy

Number and percentage of samples classified as adequate for diagnosis

Time frame: At time of cell collection

Secondary Outcomes

Human Papilloma Virus (HPV) Detection Frequency

Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay

Time frame: At the time of cell collection.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.