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

NCT ID: NCT01053052

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Fallopian Tube Patency Tests

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sonography with FemVue vs. HSG

FemVue sonography and HSG

Group Type: EXPERIMENTAL

Sonography with FemVue, and HSG

Intervention Type: DEVICE

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

Interventions

Sonography with FemVue, and HSG

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Femasys Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Femasys 300-001

Identifier Type: -

Identifier Source: org_study_id