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

CytoCore

Status: Completed

Conditions: Colposcopy; Biopsy

Treatments: Device: e2 Cell Collector [SoftPAP(R)]; Device: Spatula/Brush

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00474968

e2TM Cervical cell Collector

Details and patient eligibility

About

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

Full description

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.

Enrollment: 737 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

737 participants in 2 patient groups

Arm 1 - Experimental

Description:

e2 Cell Collector \[SoftPAP(R)\]

Treatment:

Device: e2 Cell Collector [SoftPAP(R)]

Arm 2 - Control

Description:

Brush/spatula

Treatment:

Device: Spatula/Brush