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.

Not Applicable

Recruiting

• Conditions: Hysteroscopy Technique; Fertility Issues; Gynecology; Visualization; Hysteroscopy; Uterus Abnormal; Infertility Female
• Interventions: Device: Visual Saline Infusion; Device: Hydrosonography

• Registration Number: NCT06394752
• Lead Sponsor: Center for Reproductive Health & Gynecology

Brief 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.

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 Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-25
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visual Saline Infusion	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.
Hydrosonography	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.

Primary Outcome Measures

Name	Time	Method
Intrauterine pathology detection rate with Visual Saline Infusion	Procedure of approximately 2-5 minute duration	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.
Intrauterine pathology detection rate with Hydrosonography	Procedure of 2-5 minute duration	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.

Secondary Outcome Measures

Name	Time	Method
Visual detection quality score (1-10)	Captured during procedure	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.
Pain during procedure	Collected on day of procedure	The research team will interview the Subject and record the level of pain experienced based on the Wong Baker pain scale
Fluid used during distention	Captured during procedure	The volume of fluid used for distention of the uterus will be documented.
Adverse events rate	Day of procedure and 24-48 hours post to procedure	Anticipated and unanticipated adverse events will be documented

Trial Locations

Locations (2)

Center for Reproductive Health & Gynecology; 🇺🇸 Beverly Hills, California, United States

Punta Mita Fertility Center; 🇲🇽 Corral Del Risco, Nayarit, Mexico