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Study of FemVue(TM) Sono Tubal Evaluation System for Sonography Evaluation of Fallopian Tubes and Uterus: Method Comparison to HSG

This study has suspended participant recruitment.
(Enrollment for this post-market study is on hold while protocol enhancements are considered by the sponsor.)
Sponsor:
Information provided by:
Femasys Inc.
ClinicalTrials.gov Identifier:
NCT01053052
First received: January 18, 2010
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Fallopian Tube Patency Tests
 Procedure: Sonography with FemVue, and HSG

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)

Further study details as provided by Femasys Inc.:

Primary Outcome Measures:
  • Concordance of evaluations of fallopian tube patency and intrauterine pathology. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subject discomfort assessment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2010
Arms Assigned Interventions
Experimental: Sonography with FemVue vs. HSG
FemVue sonography and HSG
 Procedure: Sonography with FemVue, and HSG

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053052

Locations
United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015
United States, Florida
The Research Institute of Palm Beach
Jupiter, Florida, United States, 33458
Universtiy of South Florida, Dept. of Obstetrics and Gynecology
Tampa, Florida, United States, 33606
The Palm Beach Center for Reproductive Medicine
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States, 30342
Reproductive Biology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
The Advanced IVF Institute
Naperville, Illinois, United States, 60540
Sponsors and Collaborators
Femasys Inc.
Investigators
Principal Investigator: Anna Parsons, MD University of South Florida, Dept. of Obstetrics and Gynecology
  More Information

No publications provided

Responsible Party: Sponsor Contact: Marc Finch, Vice President, Clinical and Physician Affairs, Femasys Inc
ClinicalTrials.gov Identifier: NCT01053052     History of Changes
Other Study ID Numbers: Femasys 300-001
Study First Received: January 18, 2010
Last Updated: October 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Femasys Inc.:
Patency Tests, Fallopian Tubes
Hysterosalpingography
Sonography, Medical

ClinicalTrials.gov processed this record on May 21, 2013