WithdrawnNot Applicable

Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG

Stopped: Study cancelled without recruitment

0Started 2010-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 * Chlamydia * Gonorrhea * Endometriosis * 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 Exclusion Criteria: 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

What they're measuring

Concordance of evaluations of fallopian tube patency and intrauterine pathology.

Timeframe: Day 1

Trial details

NCT IDNCT01053052

SponsorFemasys Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Fallopian Tube Patency Tests trials