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Béa Applicator and Béa Cervical Cap Safety and Usability Study

NCT05129553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-11-22

No results posted yet for this study

Summary

This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.

Conditions

  • Safety and Usability

Interventions

DEVICE

Béa Applicator and Béa Cervical Cap Device

Single-use of the investigational device

Sponsors & Collaborators

  • StepOne Fertility

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-08-01
Completion
2022-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129553 on ClinicalTrials.gov