N/A
Completed N=150
Clinician-Collected Versus Patient-Collected Cervical Pap Smears
Source: ClinicalTrials.gov NCT01214330 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests — 8; 89; 2; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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
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. Informational only — not medical advice.