Hydrosonography vs Visual Saline Infusion for Uterine Abnormalities

Recruiting at 1 trial location

Overseen By Alexander Nadal, MBA

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Center for Reproductive Health & Gynecology

Disqualifiers: Chlamydia, Gonorrhea, Pregnancy, IUD, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 4 6 7 8}

Research Team

Sam Najmabadi, MD

Principal Investigator

Center for Reproductive Health & Gynecology

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Hydrosonography (Procedure)
• Visual Saline Infusion Device (Procedure)

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).

Participant Groups

Group I: Visual Saline Infusion Experimental Treatment 1 Intervention

Visual Saline Infusion is intended to perform direct visual evaluation of the intrauterine space using a 2.7mm, steerable tip catheter with a camera.

Group II: Hydrosonography Active Control 1 Intervention

Hydrosonography is the standard of care for intrauterine evaluation. It is performed by inserting a slim 2 mm catheter into the uterine cavity and infusing saline solution to expand the uterus, and using abdominal ultrasound to detect intrauterine pathology.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast hysterosonography: an efficient means of investigation in gynecology. Review of the literature]. van den Brûle, FA., Wéry, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contrast hysterosonography: indications and technic]. van den Brûle, FA., Wéry, O., Gaspard, UJ.[2017]

Saline infusion sonohysterography is a safe and effective method for enhancing imaging of the uterine cavity, particularly useful for detecting intrauterine pathology.

Using chorionic villus sampling (CVS) catheters in women with cervical stenosis allows for a single-pass technique that simplifies the procedure and has been successful in 12 cases without significant discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of chorionic villus biopsy catheters for saline infusion sonohysterography. Platt, LD., Agarwal, SK., Greene, N.[2016]

Saline infusion sonography has been shown to have high diagnostic accuracy and may effectively replace diagnostic hysteroscopy for evaluating the uterine cavity in women with abnormal uterine bleeding.

Recent advancements, such as using gel for better visualization and developing guided biopsy techniques, enhance the utility of saline infusion sonography, making it a cost-effective alternative to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline infusion sonography in women with abnormal uterine bleeding: an update of recent findings. de Kroon, CD., Jansen, FW.[2016]

Saline infusion sonohysterography is a safe and effective imaging technique for evaluating the uterus and endometrium, particularly useful for diagnosing abnormal uterine bleeding.

This procedure should be avoided in pregnant women, those who could be pregnant, or individuals with pelvic infections or unexplained pelvic tenderness, highlighting the importance of proper patient selection and physician training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography. Breitkopf, D., Goldstein, SR., Seeds, JW.[2019]

Saline infusion sonohysterography is a safe and effective imaging technique for evaluating the uterus and endometrium, particularly useful for diagnosing abnormal uterine bleeding.

It is crucial that this procedure is not performed on pregnant women, those who may be pregnant, or individuals with pelvic infections or unexplained pelvic tenderness, highlighting the importance of proper patient selection and physician training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline infusion sonohysterography. [2019]

Hydrosonography, which involves the intrauterine instillation of saline during ultrasound imaging, significantly improves the detection of intrauterine abnormalities in women with abnormal uterine bleeding, identifying lesions missed by routine ultrasound in 4 out of 12 cases confirmed by hysteroscopy or hysterectomy.

This technique is safe and effective, as it reliably indicates the presence of pathological conditions, ensuring that a normal hydrosonography result correlates with a normal intrauterine cavity, making it a valuable tool for guiding further treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of transvaginal hydrosonography in the evaluation of abnormal uterine bleeding. Williams, CD., Marshburn, PB.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

[Contrast hysterosonography: an efficient means of investigation in gynecology. Review of the literature]. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Saline infusion sonohysterography. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Contrast hysterosonography: indications and technic]. [2017]

4. England pubmed.ncbi.nlm.nih.gov

The use of chorionic villus biopsy catheters for saline infusion sonohysterography. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Saline infusion sonography in women with abnormal uterine bleeding: an update of recent findings. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Saline infusion sonohysterography. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A prospective study of transvaginal hydrosonography in the evaluation of abnormal uterine bleeding. [2019]