Cervical Cap InseminationNCT01564940
Human Factors Usability Study of Ib2C Conception System
An observational study of Cervical Cap Insemination, run by Rinovum Women's Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cap Insemination
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females between the ages of 20 and 45.
Who may be able to join
- Female, any ethnicity
- 20 - 45 years of age
- Sexually active
- Signed Informed Consent
Who cannot join
- Prior surgery to the cervix or vaginal tract
- Vaginal prolapse
- Cervical cancer
- Hysterectomy
- History of Toxic Shock Syndrome (TSS)
Trial locations and contacts
1 site in 1 country.
United States1 site
Forbes Regional Hospital
Monroeville, Pennsylvania, 15146
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cap Insemination
- Keywords
- Cervical cap insemination, Usability Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cap InseminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rinovum Women's Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Pelekanos, OB-GYN, Principal investigator, Forbes Regional Hospital (West Penn Allegheny Health System)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564940
- Sponsor's protocol ID
- Ib2C-11-015
- Status last verified
- Mar 2012
- First submitted
- 25 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System
- ClinicalTrials.gov ID
- NCT01564940
- Acronym / sponsor ID
- Ib2C-11-015
- Conditions
- Cervical Cap Insemination
- Keywords
- Cervical cap insemination, Usability Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rinovum Women's Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females between the ages of 20 and 45.
Key inclusion criteria (4 listed)
- Female, any ethnicity
- 20 - 45 years of age
- Sexually active
- Signed Informed Consent
Key exclusion criteria (5 listed)
- Prior surgery to the cervix or vaginal tract
- Vaginal prolapse
- Cervical cancer
- Hysterectomy
- History of Toxic Shock Syndrome (TSS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Pelekanos, OB-GYN principal investigator
Forbes Regional Hospital (West Penn Allegheny Health System)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cap Insemination, run by Rinovum Women's Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2012.