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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36460

Enrollment

155

Registered

2010-11-30

Start date

2010-12-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

user acceptability vaginal sampling device

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results