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N/A N=150 Prevention

Clinician-Collected Versus Patient-Collected Cervical Pap Smears

Cervical Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01214330 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests — 8; 89; 2; 3 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Patient-Collected Cervical Pap Smear (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Mike O'Callaghan Military Hospital
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests		 8; 89; 2; 3 —
SECONDARY
Patient Opinions		 36; 65; 45; 91; 11; 44 —

Summary

The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.

Eligibility Criteria

Inclusion Criteria

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding

Exclusion Criteria

  • Age <18 years (not recommended for Pap Smear)
  • Known pregnancy
  • Women who have had a total hysterectomy (cervix removed)
  • Women with vaginal bleeding
  • Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01214330). 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.

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