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Completed

NCT Number: NCT00474968

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

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

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Key information

Conditions

Colposcopy Biopsy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Visions Clinical Research, Wellington, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

e2 Cell Collector [SoftPAP(R)]

Device

Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]

Spatula/Brush

Device

Cervical cells collected using a combination of a cervical spatula and an endocervical brush

Primary outcomes

  1. Cell Collection Efficacy

    Time frame: 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.

  2. Specimen Adequacy

    Time frame: At time of cell collection

    Number and percentage of samples classified as adequate for diagnosis

Secondary outcomes

  1. Human Papilloma Virus (HPV) Detection Frequency

    Time frame: At the time of cell collection.

    Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay

Sponsors and collaborators

Lead sponsor

CytoCore, Inc.

Industry

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 17, 2007
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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