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

Completed

• Conditions: Colposcopy; Biopsy
• Interventions: Device: e2 Cell Collector [SoftPAP(R)]; Device: Spatula/Brush

• Registration Number: NCT00474968
• Lead Sponsor: CytoCore, Inc.

Brief 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-17
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-05-04
• Results First Submitted QC: 2009-06-29
• Results First Posted: 2009-08-13
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-16
• Last Update Posted: 2009-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 737

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1 - Experimental	e2 Cell Collector [SoftPAP(R)]	e2 Cell Collector \[SoftPAP(R)\]
Arm 2 - Control	Spatula/Brush	Brush/spatula

Primary Outcome Measures

Name	Time	Method
Cell Collection Efficacy	At the time of cell collection.	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.
Specimen Adequacy	At time of cell collection	Number and percentage of samples classified as adequate for diagnosis

Secondary Outcome Measures

Name	Time	Method
Human Papilloma Virus (HPV) Detection Frequency	At the time of cell collection.	Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay

Trial Locations

Locations (7)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Comprehensive Clinical Trials; 🇺🇸 West Palm Beach, Florida, United States

St. Louis University; 🇺🇸 St. Louis, Missouri, United States

Visions Clinical Research; 🇺🇸 Wellington, Florida, United States

University of Pittsburgh Medical Centers; 🇺🇸 Pittsburgh, Pennsylvania, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

Baylor Research Institute; 🇺🇸 Fort Worth, Texas, United States