NCT01214330

Clinician-Collected Versus Patient-Collected Cervical Pap Smears

A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Mike O'Callaghan Military Hospital · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The SoloPap "kit" provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DEVICE	Patient-Collected Cervical Pap Smear	Patient-Collected Cervical Papanicolaou Smear

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-10-05
• Last updated: 2024-03-12
• Results posted: 2014-11-20

Locations

1 site across 1 country: United States