Human Factors Usability Study of Ib2C Conception System

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Intimate bridge 2 Conception, Inc.

ClinicalTrials.gov Identifier:

NCT01564940

First received: March 25, 2012

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 25, 2012

Last Updated Date

March 27, 2012

Start Date ^ICMJE

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01564940 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Human Factors Usability Study of Ib2C Conception System

Official Title ^ICMJE

Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Females between the ages of 20 and 45.

Condition ^ICMJE

Cervical Cap Insemination

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01564940

Other Study ID Numbers ^ICMJE

Ib2C-11-015

Has Data Monitoring Committee

Yes

Responsible Party

Intimate bridge 2 Conception, Inc.

Study Sponsor ^ICMJE

Intimate bridge 2 Conception, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael J Pelekanos, OB-GYN

Forbes Regional Hospital (West Penn Allegheny Health System)

Information Provided By

Intimate bridge 2 Conception, Inc.

Verification Date

March 2012

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

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