Evaluation of an improved self-lavaging device, the Delphi® Screener

Completed

Conditions: user acceptability vaginal sampling device
10013364

Registration Number: NL-OMON36460

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 155

Inclusion Criteria

-Women
-30 years or older
-self-report being able to read in Dutch
-Body Mass Index > 33 in at least 15% of participants
-willing to return the specimen and study documents to the study coordinator within 24 hours after collection
-willing to sign informed consent

Exclusion Criteria

no uterus/ history of complete hysterectomy
mental or physical handicap that would prevent self-collection of specimens

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives<br /><br>• To evaluate the acceptance and user-friendliness of the modified Delphi<br /><br>Screener as a method to collect a specimen for use of cervical cancer screening.<br /><br>• To evaluate the functionality of the modified Delphi Screener: the plunging<br /><br>system, automatic retrieving system, indicator reading system, single use<br /><br>system (blocking). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives<br /><br>• To compare user experiences between women using the device in lying position<br /><br>at home vs sitting down in lavatory vs upright position<br /><br>• To evaluate user experience in obese women.<br /><br>• To evaluate the perception how to use the device of women without user<br /><br>instructions (20%).<br /><br>• To evaluate the user-friendliness of the user instructions in the group of<br /><br>women with access to the UIs<br /><br>• To evaluate the specimen handling procedure and processing procedure in the<br /><br>laboratory as laid down in this protocol in relation to HPV primary testing.<br /><br>• To measure the amount of fluid collected using the Delphi Screener.<br /><br>• To measure pellet size.<br /><br>• To determine the percentage of indeterminate or insufficient specimen<br /><br>collections for the Screener by b-globin testing.<br /><br>• To record any adverse event that occurs from use of the device, as a<br /><br>measurement of safety.</p><br>