Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG
NCT01053052 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2017-05-09
Summary
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.
Conditions
- Fallopian Tube Patency Tests
Interventions
- DEVICE
-
Sonography with FemVue, and HSG
Sono HSG for FDA 510(k) cleared indication for use
Sponsors & Collaborators
-
Femasys Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
- FDA Device
- Yes
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