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

Not Applicable

Withdrawn

• Conditions: Fallopian Tube Patency Tests
• Interventions: Device: Sonography with FemVue, and HSG

• Registration Number: NCT01053052
• Lead Sponsor: Femasys Inc.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sonography with FemVue vs. HSG	Sonography with FemVue, and HSG	FemVue sonography and HSG

Primary Outcome Measures

Name	Time	Method
Concordance of evaluations of fallopian tube patency and intrauterine pathology.	Day 1

Secondary Outcome Measures

Name	Time	Method
subject discomfort assessment	Day 1