Forbes Regional Hospital
Monroeville, Pennsylvania, 15146, United States
Completed
NCT Number: NCT01564940
Human Factors Usability Study of Ib2C Conception System
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.
Completed
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Conditions
Age range
20 year–45 year
Sex eligibility
Female
Study type
Observational
Primary location
About this study
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Female, any ethnicity
- 20 - 45 years of age
- Sexually active
- Signed Informed Consent
Exclusion criteria
- Prior surgery to the cervix or vaginal tract
- Vaginal prolapse
- Cervical cancer
- Hysterectomy
- History of Toxic Shock Syndrome (TSS)
Sponsors and collaborators
Lead sponsor
Rinovum Women's Health, Inc.
Industry
Registry information
Official study title
Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Mar 28, 2012
- Registry last updated
- Mar 28, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.