NCT00474968

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

Clinical Study Validating the Adequacy, Efficacy, and Safety of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique In Patients With Recent History of Abnormal Pap Test Returning for Colposcopy/Biopsy.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 737 (actual)
• Sponsor: CytoCore, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Colposcopy
• Biopsy

Interventions

Type	Name	Description
DEVICE	e2 Cell Collector [SoftPAP(R)]	Cervical cells collected using the e2 Cell Collector \[SoftPAP(R)\]
DEVICE	Spatula/Brush	Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-05-17
• Last updated: 2009-11-20
• Results posted: 2009-08-13

Locations

7 sites across 1 country: United States