UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY. This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography, and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus.

Fertility Issues Clinical Trial

Official title:

UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06394752
• Other study ID #: TD-1033
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: Center for Reproductive Health & Gynecology
• Contact: Alexander Nadal, MBA
• Phone: 323-420-6343
• Email: nadalalex[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Patients who are enrolled in the study will have a 1) Hydrosonography, and 2) Visual Saline Infusion procedure performed.

The Visual Saline Infusion Device is a 2.7mm, steerable tip catheter with a camera and illumination at the distal end. The device is intended to evaluate the intrauterine space in an office based, outpatient setting using minimal volume of fluid (3-5cc's).

This study will recruit up to 100 women from a fertility center in Los Angeles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients requiring a uterine cavity evaluation

2. Premenopausal women between ages of 18-45

Exclusion Criteria:

1. Positive test or history of any of the following conditions:

1a. Chlamydial pelvic infection

1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place

Related Conditions & MeSH terms

• Fertility Issues
• Gynecology
• Hysteroscopy
• Hysteroscopy Technique
• Infertility
• Infertility Female
• Infertility, Female
• Uterus Abnormal

Intervention

Device:
• Visual Saline Infusion
Visual Saline Infusion (VSI) is a new intrauterine imaging procedure to identify uterine pathology. The VSI device is a 2.7mm, steerable tip catheter with a camera and illumination at the distal end. The device is intended to evaluate the intrauterine space in an office based, outpatient setting using minimal volume of fluid (3-5cc's).
• Hydrosonography
Hydrosonography is an ultrasound based intrauterine imaging technique with sensitivity and specificity ranging from 90% to 100% for identifying uterine pathology. 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 visualize the uterus.

Locations

Country	Name	City	State
Mexico	Punta Mita Fertility Center	Corral Del Risco	Nayarit
United States	Center for Reproductive Health & Gynecology	Beverly Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Center for Reproductive Health & Gynecology	Butterfly Biosciences, Inc

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrauterine pathology detection rate with Hydrosonography	The assessment will involve the examination of the intrauterine cavity for the presence of pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.	Procedure of 2-5 minute duration
Primary	Intrauterine pathology detection rate with Visual Saline Infusion	The assessment will involve the examination of the intrauterine cavity for the presence of known pathologies, including polyps, fibroids, adhesions, scar tissue, thickened endometrium, among others. The detection rate will be calculated as the ratio of the number of cases where abnormal pathologies are identified to the total number of cases examined.	Procedure of approximately 2-5 minute duration
Secondary	Visual detection quality score (1-10)	The visual detection quality score will be assessed using a normalized scale ranging from 1 (indicating poor or no visualization) to 10 (indicating excellent visualization), with scores assigned based on the clarity and detail of the intrauterine images obtained during the examination.	Captured during procedure
Secondary	Fluid used during distention	The volume of fluid used for distention of the uterus will be documented.	Captured during procedure
Secondary	Pain during procedure	The research team will interview the Subject and record the level of pain experienced based on the Wong Baker pain scale	Collected on day of procedure
Secondary	Adverse events rate	Anticipated and unanticipated adverse events will be documented	Day of procedure and 24-48 hours post to procedure