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

A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053052

Enrollment

Registered

2010-01-21

Start date

2010-01-31

Completion date

2013-01-31

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Patency Tests

Keywords

Patency Tests, Fallopian Tubes, Hysterosalpingography, Sonography, Medical

Brief 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.

Detailed description

Study cancelled prior to recruitment.

Interventions

DEVICESonography with FemVue, and HSG

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Concordance of evaluations of fallopian tube patency and intrauterine pathology.	Day 1

Secondary

Measure	Time frame
subject discomfort assessment	Day 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026