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

F

Femasys

Status

Withdrawn

Conditions

Fallopian Tube Patency Tests

Treatments

Device: Sonography with FemVue, and HSG

Study type

Interventional

Funder types

Industry

Identifiers

NCT01053052
Femasys 300-001

Details and patient eligibility

About

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.

Full description

Study cancelled prior to recruitment.

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Sonography with FemVue vs. HSG
Experimental group
Description:
FemVue sonography and HSG
Treatment:
Device: Sonography with FemVue, and HSG

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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