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.

UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Issues; Hysteroscopy; Gynecology; Hysteroscopy Technique; Uterus Abnormal; Infertility Female; Visualization
• Intervention / Treatment: Device: Visual Saline Infusion; Device: Hydrosonography

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Nadal, MBA; Phone Number: 323-420-6343; Email: nadalalex@berkeley.edu
• Study Contact Backup: Name: Sam Najmabadi, MD; Phone Number: 310-360-7584; Email: najmabadi@reproductive.org

Study Locations

• Mexico
  • Nayarit
    • Corral Del Risco, Nayarit, Mexico, 63734
      • Not yet recruiting
      • Punta Mita Fertility Center
      • Contact: Jose Luis Rivas, MD; Email: drrivas@puntamitahospital.com
      • Principal Investigator: Dr. Jose Luis Rivas, MD
• United States
  • California
    • Beverly Hills, California, United States, 90007
      • Recruiting
      • Center for Reproductive Health & Gynecology
      • Principal Investigator: Sam Najmabadi, MD
      • Contact: Spencer Wendt; Phone Number: 310-360-7584; Email: info@reproductive.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual Saline Infusion; Visual Saline Infusion is intended to perform direct visual evaluation of the intrauterine space using a 2.7mm, steerable tip catheter with a camera.	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).
Active Comparator: Hydrosonography; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fluid used during distention	The volume of fluid used for distention of the uterus will be documented.	Captured during procedure
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
Adverse events rate	Anticipated and unanticipated adverse events will be documented	Day of procedure and 24-48 hours post to procedure

Collaborators and Investigators

• Sponsor: Center for Reproductive Health & Gynecology
• Collaborators: Butterfly Biosciences, Inc
• Investigators: Principal Investigator: Sam Najmabadi, MD, Center for Reproductive Health & Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: hysteroscopy; fertility; gynecology; hydrosonography; uterine evaluation; uterine pathology
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: TD-1033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes