N/A
Completed N=737
Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.
Colposcopy · Biopsy
Source: ClinicalTrials.gov NCT00474968 ↗
Enrolled (actual)
737
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Cell Collection Efficacy — 174; 170; 33; 14 Participants
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
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 | — |
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.
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. Informational only — not medical advice.