At a glance
ClinicalIndex Comparison RecordN/ACompleted· 737 enrolled
Drug / intervention
e2 Cell Collector [SoftPAP(R)] +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
An observational study evaluating e2 Cell Collector [SoftPAP(R)] and Spatula/Brush for Colposcopy and Biopsy. Completed, enrolled 737 participants across 7 sites.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsColposcopy, Biopsy
CountriesUnited States
CollaboratorsUniversity Hospitals Cleveland Medical Center
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedMay 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedMay 17, 2007
Enrollment StartApr 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.1 years ago
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