Human Factors Usability Study of Ib2C Conception System

Completed

• Conditions: Cervical Cap Insemination

• Registration Number: NCT01564940
• Lead Sponsor: Rinovum Women's Health, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-25
• Study First Submitted QC: 2012-03-27
• Last Update Submitted: 2012-03-27
• Study First Posted: 2012-03-28
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Forbes Regional Hospital; 🇺🇸 Monroeville, Pennsylvania, United States