CClinicalTrials.gg
Sign In
WithdrawnNCT01053052Updated May 9, 2017

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

An interventional study of Sonography with FemVue, and HSG in Fallopian Tube Patency Tests, sponsored by Femasys Inc.. Withdrawn. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Femasys Inc. · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Study cancelled without recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description

Study cancelled prior to recruitment.

02

Conditions studied

  • Fallopian Tube Patency Tests

Keywords

  • Patency Tests, Fallopian Tubes
  • Hysterosalpingography
  • Sonography, Medical
03

In context

Lead sponsor

Femasys Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Sonography with FemVue vs. HSG

    FemVue sonography and HSG

    Device: Sonography with FemVue, and HSG

Interventions

  • DeviceSonography with FemVue, and HSG

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

06

What researchers measure

Primary outcomes

  1. Concordance of evaluations of fallopian tube patency and intrauterine pathology.

    Time frame: Day 1

Secondary outcomes

  1. subject discomfort assessment

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01053052
Lead sponsor
Femasys Inc.
Responsible party
Sponsor
First posted
Jan 21, 2010
Start date
Jan 2010
Primary completion
Jan 2013
Completion
Jan 2013
Last update
May 9, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Femasys Inc.

Start the discussion