N/A N=737

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

Colposcopy · Biopsy

Bottom Line

View on ClinicalTrials.gov: NCT00474968 ↗

Enrolled (actual)

737

Serious AEs

0.0%

Results posted

Aug 2009

Primary outcome: Primary: Cell Collection Efficacy — 174; 170; 33; 14 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: e2 Cell Collector [SoftPAP(R)] (Device); Spatula/Brush (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: CytoCore, Inc.
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Cell Collection Efficacy	174; 170; 33; 14; 42; 63	—
PRIMARY Specimen Adequacy	343; 352; 4; 2; 1; 1	—
SECONDARY Human Papilloma Virus (HPV) Detection Frequency	165; 214; 82; 104; 101; 37	—

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

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00474968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.