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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

March 25, 2012
March 27, 2012
September 2011
September 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01564940 on ClinicalTrials.gov Archive Site
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Human Factors Usability Study of Ib2C Conception System
Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. 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.

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.

Observational
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Probability Sample

Females between the ages of 20 and 45.

Cervical Cap Insemination
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2011
September 2011   (final data collection date for primary outcome measure)

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)
Female
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01564940
Ib2C-11-015
Yes
Rinovum Women's Health, Inc.
Rinovum Women's Health, Inc.
Not Provided
Principal Investigator: Michael J Pelekanos, OB-GYN Forbes Regional Hospital (West Penn Allegheny Health System)
Rinovum Women's Health, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP