100 Participants Needed

Hydrosonography vs Visual Saline Infusion for Uterine Abnormalities

Recruiting at 1 trial location
AN
SN
Overseen BySam Najmabadi, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Center for Reproductive Health & Gynecology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is saline infusion sonohysterography safe for humans?

Saline infusion sonohysterography is generally considered safe when performed correctly, but it should not be done on pregnant women or those with pelvic infections or unexplained pelvic pain.12345

How is the Visual Saline Infusion Device treatment different from other treatments for uterine abnormalities?

The Visual Saline Infusion Device treatment is unique because it uses a real-time ultrasound with sterile saline injected into the uterus to enhance imaging, allowing for a clearer view of the uterine cavity to detect abnormalities. This method is non-invasive and provides detailed information about the uterus and endometrium, which is particularly useful for diagnosing issues like abnormal uterine bleeding.12346

What data supports the effectiveness of this treatment for uterine abnormalities?

Saline infusion sonography (SIS) is a safe and cost-effective method that enhances ultrasound imaging of the uterine cavity, helping to diagnose conditions like polyps and fibroids. It is well tolerated by patients and can reduce the need for more invasive procedures.12578

Who Is on the Research Team?

SN

Sam Najmabadi, MD

Principal Investigator

Center for Reproductive Health & Gynecology

Are You a Good Fit for This Trial?

This trial is for women of reproductive age who may have uterine abnormalities affecting fertility. Participants should not be currently pregnant, and must be willing to undergo diagnostic procedures to examine the inside of their uterus.

Inclusion Criteria

I am a woman aged 18-45 and have not gone through menopause.
I need a check-up of the inside of my uterus.

Exclusion Criteria

Positive test or history of chlamydial pelvic infection
Positive Pregnancy Test
Positive test or history of gonorrheal pelvic infection
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo Hydrosonography and Visual Saline Infusion procedures to evaluate intrauterine pathology

1 day
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and pain levels post-procedure

1-2 days
Follow-up via phone or in-person

What Are the Treatments Tested in This Trial?

Interventions

  • Hydrosonography
  • Visual Saline Infusion Device
Trial Overview The study is comparing two methods used to detect problems inside the uterus: a new device that allows doctors to see directly into the uterus with saline infusion (VSI), versus the usual method using sound waves in water (Hydrosonography).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Visual Saline InfusionExperimental Treatment1 Intervention
Group II: HydrosonographyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Center for Reproductive Health & Gynecology

Lead Sponsor

Trials
1
Recruited
100+

Butterfly Biosciences, Inc

Collaborator

Trials
1
Recruited
100+

Published Research Related to This Trial

Contrast-enhanced vaginosonography is an innovative imaging technique that improves the visualization of the uterine cavity, allowing for the detection of various intrauterine pathologies such as polyps and myomas.
Saline infusion sonography (SIS), introduced in 1996, is a key method for evaluating endouterine conditions, providing precise imaging that can help in diagnosing and managing uterine abnormalities.
[Contrast hysterosonography: an efficient means of investigation in gynecology. Review of the literature].van den Brรปle, FA., Wรฉry, O., Huveneers, J., et al.[2017]
Saline infusion sonography improves the quality of endovaginal ultrasound examinations of the uterine cavity, making it a valuable tool in gynecological assessments.
This procedure is quick, cost-effective, and well-tolerated by patients, with minimal risk of complications, potentially reducing the need for more invasive diagnostic methods.
Saline infusion sonohysterography.Goldstein, SR.[2022]
Saline infusion sonography (SIS) is an innovative technique that enhances the visualization of the uterine cavity, allowing for accurate diagnosis of conditions like endometrial polyps and myomas.
The article outlines the procedure for SIS, including its indications and contraindications, highlighting its importance in identifying various intrauterine pathologies.
[Contrast hysterosonography: indications and technic].van den Brรปle, FA., Wรฉry, O., Gaspard, UJ.[2017]

Citations

[Contrast hysterosonography: an efficient means of investigation in gynecology. Review of the literature]. [2017]
Saline infusion sonohysterography. [2022]
[Contrast hysterosonography: indications and technic]. [2017]
The use of chorionic villus biopsy catheters for saline infusion sonohysterography. [2016]
Saline infusion sonography in women with abnormal uterine bleeding: an update of recent findings. [2016]
ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography. [2019]
Saline infusion sonohysterography. [2019]
A prospective study of transvaginal hydrosonography in the evaluation of abnormal uterine bleeding. [2019]
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