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Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-Up Screening


Phase 1/Phase 2
14 Years
N/A
Not Enrolling
Female
Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia, Uterine Cervical Cancer

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Trial Information

Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-Up Screening


This study tested the feasibility, safety and efficacy of the new e2TM Collector, and
compared its performance with the standard method for obtaining cervical cells for Pap test
of endocervical cytobrush and Ayer’s Spatula


Inclusion Criteria:



Women ages >14 being followed for a previous abnormal Pap All patients will have signed an
Informed Consent form prior to being enrolled in this study

Exclusion Criteria:

Patients who have had a hysterectomy

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

George I Gorodeski, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals of Cleveland, Case Western Reserve University

Authority:

United States: Institutional Review Board

Study ID:

02-00-16

NCT ID:

NCT00266084

Start Date:

August 1999

Completion Date:

November 2001

Related Keywords:

  • Uterine Cervical Dysplasia
  • Uterine Cervical Intraepithelial Neoplasia
  • Uterine Cervical Neoplasia
  • Uterine Cervical Cancer
  • Cervix
  • Uterus
  • Dysplasia
  • Cancer
  • Collector
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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