Human Factors Usability Study of Ib2C Conception System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rinovum Women's Health, Inc.
ClinicalTrials.gov Identifier:
NCT01564940
First received: March 25, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition
Cervical Cap Insemination

Study Type: Observational
Official Title: Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System

Further study details as provided by Rinovum Women's Health, Inc.:

Enrollment: 15
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Females between the ages of 20 and 45.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564940

Locations
United States, Pennsylvania
Forbes Regional Hospital
Monroeville, Pennsylvania, United States, 15146
Sponsors and Collaborators
Rinovum Women's Health, Inc.
Investigators
Principal Investigator: Michael J Pelekanos, OB-GYN Forbes Regional Hospital (West Penn Allegheny Health System)
  More Information

No publications provided

Responsible Party: Rinovum Women's Health, Inc.
ClinicalTrials.gov Identifier: NCT01564940     History of Changes
Other Study ID Numbers: Ib2C-11-015
Study First Received: March 25, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rinovum Women's Health, Inc.:
Cervical cap insemination
Usability Study

ClinicalTrials.gov processed this record on April 17, 2014