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

Femasys Inc.

Overview

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.

Study cancelled prior to recruitment.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Fallopian Tube Patency Tests

Interventions

Sonography with FemVue, and HSGDEVICE

Sono HSG for FDA 510(k) cleared indication for use

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Concordance of evaluations of fallopian tube patency and intrauterine pathology.

Time frame: Day 1

Secondary Outcomes

subject discomfort assessment

Time frame: Day 1

Data from ClinicalTrials.gov

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