The Stork OTC: Collection, Placement & Delivery

NCT02038322 | Completed

• 1 other identifier: ER-000025
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Safety and Usability

Keywords

OTC Home Use Conception Aid Cervical Cap Insemination

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4-12 hrs

Secondary Outcomes (1)

• Secondary Endpoint

  up to 3 days

Study Arms (1)

The Stork

NO INTERVENTION

Device - The Stork - complete kit (Conceptacle and Applicator)

Device: The Stork - Conception Aid

Interventions

The Stork - Conception Aid DEVICE

Also known as: The Stork

The Stork

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rinovum Women's Health, Inc.: lead

Study Sites (1)

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Location

Study Officials

• Michael J Pelekanos, OB-GYN

  Forbes Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: January 16, 2014
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

US (1)