NCT01053052

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

January 18, 2010

Last Update Submit

May 8, 2017

Conditions

Fallopian Tube Patency Tests

Keywords

Patency Tests, Fallopian TubesHysterosalpingographySonography, Medical

Outcome Measures

Primary Outcomes (1)

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

    Day 1

Secondary Outcomes (1)

  • subject discomfort assessment

    Day 1

Study Arms (1)

Sonography with FemVue vs. HSG

EXPERIMENTAL

FemVue sonography and HSG

Device: Sonography with FemVue, and HSG

Interventions

Sonography with FemVue, and HSGDEVICE

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

Sonography with FemVue vs. HSG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 21, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share