Safety and UsabilityNCT02038322
The Stork OTC: Collection, Placement & Delivery
A study testing The Stork - Conception Aid in people with Safety and Usability, run by Rinovum Women's Health, Inc. at 1 site in United States.
Trial summary
This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Usability
- What is being tested?
- The Stork - Conception Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2014
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literacy must be in English (able to understand Informed Consent)
- In general good health
- Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active (as a couple)
- 18 - 50 years of age
- REALM-SF Test Results demonstrate 6th grade literacy or above
- Past experience with using condoms
- Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.
- Signed Informed Consent
Who cannot join
- Vaginal prolapsed (female)
- Hysterectomy (female)
- Erectile Dysfunction (male)
- Colposcopy with biopsy surgery within the last three (3) months (female)
- Treatment for dysplasia surgery within the last three (3) months (female)
- Vaginal/cervical surgery within the last three (3) months (female)
- Current Pregnancy (female)
- Unable to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Forbes Regional Hospital
Monroeville, Pennsylvania, 15146
About this study
Official title: The Stork™ Conception System (OTC) Clinical Trial: Semen Collection, Placement and Delivery
This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal
Read the detailed description
Female participants will undergo a baseline pelvic examination. Participating couples will be given The Stork™ Conception System (OTC), including Instructions for Use, the questionnaire and two ziplock bags. The device will be used in accordance with the instructions for use. Participants will use the Conceptacle as a collection condom during sexual intercourse. Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the Sheath. Participants will then load the Cervical Cap into the Applicator for insertion, placement and deployment of the device. Participants will wash the applicator with soap and water and place it in the double zip lock bags. During the time the cervical cap is inserted, normal activity will be recommended with the exception of having intercourse. The female participants will leave the conception cap inserted for a period of time between 4 and 12 hours, return to the investigator's office for examination, remove the Cervical Cap, and undergo a follow up pelvic examination. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. As a result, this study could take up to 4 days to complete per enrolled couple.
- Conditions
- Safety and Usability
- Being tested
- The Stork - Conception Aid
- Keywords
- OTC Home Use Conception Aid Cervical Cap Insemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Stork - Conception AidDevice
Also called The Stork
| Study group | Role | What they receive |
|---|---|---|
| The Stork | No intervention | Device - The Stork - complete kit (Conceptacle and Applicator) Receives: Device: The Stork - Conception Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy -Primary endpoint part 1 - Collection
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met. The three parts of the endpoint are:
P1: Participants indicate ability to collect and contain semen using the Conceptacle™.
The examinations will occur 4-12 hours after device insertion.
Measured: 1-3 days
Efficacy - Primary endpoint part 2 - Placement
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met.
P2: Successful placement of the cervical cap as determined by physical examination.
Measured: 4-12 hrs
Primary endpoint part 3 -Safety
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met.
P3: Participants use the device without any evidence of damage to the female participants' genital tract as depicted by physician examination.
Measured: 4-12 hrs
Secondary outcomes (1)
Secondary Endpoint
Secondary Objectives: Pass/Fail Answers to the specific questions Male 1-3 and Female 1-4 on the CRF will be compiled descriptively to indicate participant success during the study.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and UsabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038322
- Sponsor's protocol ID
- ER-000025
- Status last verified
- Jan 2014
- First submitted
- 28 Oct 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stork™ Conception System (OTC) Clinical Trial: Semen Collection, Placement and Delivery
- ClinicalTrials.gov ID
- NCT02038322
- Acronym / sponsor ID
- ER-000025
- Conditions
- Safety and Usability
- Keywords
- OTC Home Use Conception Aid Cervical Cap Insemination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Rinovum Women's Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Jan 2014 (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.
This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal
Detailed description
Female participants will undergo a baseline pelvic examination. Participating couples will be given The Stork™ Conception System (OTC), including Instructions for Use, the questionnaire and two ziplock bags. The device will be used in accordance with the instructions for use. Participants will use the Conceptacle as a collection condom during sexual intercourse. Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the Sheath. Participants will then load the Cervical Cap into the Applicator for insertion, placement and deployment of the device. Participants will wash the applicator with soap and water and place it in the double zip lock bags. During the time the cervical cap is inserted, normal activity will be recommended with the exception of having intercourse. The female participants will leave the conception cap inserted for a period of time between 4 and 12 hours, return to the investigator's office for examination, remove the Cervical Cap, and undergo a follow up pelvic examination. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. As a result, this study could take up to 4 days to complete per enrolled couple.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Stork | No intervention | Device: The Stork - Conception AidDevice - The Stork - complete kit (Conceptacle and Applicator) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Literacy must be in English (able to understand Informed Consent)
- In general good health
- Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active (as a couple)
- 18 - 50 years of age
- REALM-SF Test Results demonstrate 6th grade literacy or above
Key exclusion criteria (8 listed)
- Vaginal prolapsed (female)
- Hysterectomy (female)
- Erectile Dysfunction (male)
- Colposcopy with biopsy surgery within the last three (3) months (female)
- Treatment for dysplasia surgery within the last three (3) months (female)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Stork - Conception AidAlso: The Stork | Device | The Stork |
Primary outcome
Efficacy -Primary endpoint part 1 - Collection
Time frame: 1-3 days
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met. The three parts of the endpoint are: P1: Participants indicate ability to collect and contain semen using the Conceptacle™. The examinations will occur 4-12 hours after device insertion.
Efficacy - Primary endpoint part 2 - Placement
Time frame: 4-12 hrs
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met. P2: Successful placement of the cervical cap as determined by physical examination.
Primary endpoint part 3 -Safety
Time frame: 4-12 hrs
The primary endpoint of the study is comprised of 3 parts. It is binary, in the sense that if all of the three parts are "passed" then the endpoint is met for that couple. If any part of the endpoint is not met then the endpoint for that couple is not met. P3: Participants use the device without any evidence of damage to the female participants' genital tract as depicted by physician examination.
1 secondary outcome
Secondary Endpoint
Time frame: up to 3 days
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 16 Jan 2014.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Stork - Conception Aid in people with Safety and Usability, 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 8 inclusion and 8 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 16 Jan 2014. 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.
What does the primary outcome measure?
Efficacy -Primary endpoint part 1 - Collection (time frame: 1-3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 16 Jan 2014.