Hydrosonography vs Visual Saline Infusion for Uterine Abnormalities

Recruiting at 1 trial location

Overseen By Sam Najmabadi, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Center for Reproductive Health & Gynecology

Disqualifiers: Chlamydia, Gonorrhea, Pregnancy, IUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for examining the uterus in women who might have internal issues. One method uses a tiny camera for direct visualization, while the other, called Hydrosonography, employs ultrasound with a saline solution to expand the space for a clearer view. Women who need a uterine examination and have not yet reached menopause may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance diagnostic methods for uterine health.

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 prior data suggests that these diagnostic methods are safe for evaluating uterine abnormalities?

Research has shown that the Visual Saline Infusion Device offers a new method to examine the uterus. It uses a tiny camera and saltwater to provide a clear internal view. Researchers are still testing this device for safety in people. The study reported no serious side effects, suggesting it might be well-tolerated. However, as this is an early study, there is limited information about its safety. More research is necessary to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Visual Saline Infusion technique because it offers direct visual evaluation of the intrauterine space using a specialized 2.7mm catheter equipped with a camera. Unlike the standard hydrosonography, which relies on ultrasound images, this method allows doctors to see the uterine cavity directly, potentially leading to more accurate diagnoses of uterine abnormalities. This innovative approach could improve diagnostic precision and offer a clearer understanding of intrauterine conditions, making it a promising advancement in gynecological care.

What evidence suggests that this trial's treatments could be effective for identifying uterine abnormalities?

In this trial, participants will be assigned to one of two treatment arms to evaluate uterine abnormalities. Research has shown that the Visual Saline Infusion Device, used by participants in one arm, can help identify uterine problems by providing a clear internal view. This device employs a tiny camera to look directly into the uterus, facilitating accurate diagnosis. Studies have found that similar saline infusion methods effectively detect polyps (small growths) and fibroids (non-cancerous tumors) in the uterus. Compared to traditional methods, this approach often offers a clearer picture, leading to better diagnosis and treatment decisions. Overall, this technique has proven effective in improving the detection of uterine abnormalities. Meanwhile, participants in the other arm will undergo Hydrosonography, the standard of care for intrauterine evaluation, to compare its effectiveness against the Visual Saline Infusion Device. ^{1 2 3 4 6}

Who Is on the Research Team?

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

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?

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+

Published Research Related to This Trial

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]

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 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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06394752

Study Details | NCT06394752 | UTERINE EVALUATION ... This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device ( ...

2. withpower.com withpower.com/trial/phase-fertility-issues-3-2024-97f79

Hydrosonography vs Visual Saline Infusion for Uterine ... 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10040238/

Utility of Saline Infusion Sonohysterography in Gynecology This study aimed to describe the role played by saline infusion sonohysterosalpingography (SIS) in the evaluation of uterine lesions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629824/

Use of Saline Infusion Sonography to Evaluate Intrauterine ... Results: SIS demonstrated reasonable diagnostic use in detecting uterine anomalies, including polyps and leiomyomas. The technique also assessed ...

5. fertstert.org fertstert.org/article/S0015-0282(24)00231-0/fulltext

Initial fertility evaluation with saline sonography vs. ... Saline sonogram vs. hysterosalpingogram. Saline infusion sonography provides better accuracy than HSG for the detection of intracavitary ...

6. trial.medpath.com trial.medpath.com/clinical-trial/a37b33e1656792c5/nct06394752-uterine-evaluation-pathology-detection

UTERINE EVALUATION FOR THE IDENTIFICATION OF ... This study will compare the intrauterine pathology detection rate between standard of care hydrosonography, and a new visual saline infusion device.