Human Factors Usability Study of Ib2C Conception System

NCT ID: NCT01564940

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Cervical Cap Insemination

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rinovum Women's Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Pelekanos, OB-GYN

Role: PRINCIPAL_INVESTIGATOR

Forbes Regional Hospital (West Penn Allegheny Health System)

Locations

Forbes Regional Hospital

Monroeville, Pennsylvania, United States

Countries

United States

Other Identifiers

Ib2C-11-015

Identifier Type: -

Identifier Source: org_study_id