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.
Device: Sonography with FemVue, and HSG
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Full eligibility criteria for NCT01053052
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have:
Been attempting conception for 6 months or
A history of PID (including the conditions listed below) or
A history of pelvic surgery or
Advanced maternal age (≥ 35) And
Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment
Without current bi-lateral tubal sterilization
Signed Informed Consent
Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure)
obstructing access to uterine cornu
distorting fundus at the midline region
All locations for NCT01053052
View full eligibility
Tris trial is registered with FDA with number: NCT01053052. The sponsor of the trial is Femasys Inc. and it is looking for 0 volunteers for the current phase.
Official trial title: A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)
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