ClinicalTrials.Veeva

Menu

Human Factors Usability Study of Ib2C Conception System

R

Rinovum

Status

Completed

Conditions

Cervical Cap Insemination

Study type

Observational

Funder types

Industry

Identifiers

NCT01564940
Ib2C-11-015

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems