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

This study has been withdrawn prior to enrollment.
(Study cancelled without recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053052
First Posted: January 21, 2010
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Femasys Inc.
  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 Device: Sonography with FemVue, and HSG

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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)

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • subject discomfort assessment [ Time Frame: Day 1 ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sonography with FemVue vs. HSG
FemVue sonography and HSG
Device: Sonography with FemVue, and HSG
Sono HSG for FDA 510(k) cleared indication for use

Detailed Description:
Study cancelled prior to recruitment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
No Contacts or Locations Provided
  More Information

Responsible Party: Femasys Inc.
ClinicalTrials.gov Identifier: NCT01053052     History of Changes
Other Study ID Numbers: Femasys 300-001
First Submitted: January 18, 2010
First Posted: January 21, 2010
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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