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Human Factors Usability Study of Ib2C Conception System

NCT01564940 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2012-03-28

No results posted yet for this study

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.

Conditions

  • Cervical Cap Insemination

Sponsors & Collaborators

  • Rinovum Women's Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Pelekanos, OB-GYN · Forbes Regional Hospital (West Penn Allegheny Health System)

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564940 on ClinicalTrials.gov