Clinical trial NCT06394752: 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.
Official title: UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysteroscopy
Hysteroscopy Technique
Fertility Issues
Uterus Abnormal
Gynecology
Visualization
Infertility Female
Keywords: hysteroscopy
fertility
gynecology
hydrosonography
uterine evaluation
uterine pathology
Lead sponsor: Center for Reproductive Health & Gynecology
Sponsor class: OTHER
Collaborators: name: Butterfly Biosciences, Inc
First posted: 2024-05-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intrauterine pathology detection rate with Hydrosonography
timeFrame: Procedure of 2-5 minute duration
measure: Intrauterine pathology detection rate with Visual Saline Infusion
timeFrame: Procedure of approximately 2-5 minute duration
Secondary outcomes:
measure: Visual detection quality score (1-10)
timeFrame: Captured during procedure
measure: Fluid used during distention
timeFrame: Captured during procedure
measure: Pain during procedure
timeFrame: Collected on day of procedure
measure: Adverse events rate
timeFrame: Day of procedure and 24-48 hours post to procedure
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Center for Reproductive Health & Gynecology
state: California
city: Corral Del Risco
country: Mexico
facility: Punta Mita Fertility Center
state: Nayarit
Study officials:
affiliation: Center for Reproductive Health & Gynecology
name: Sam Najmabadi, MD
role: PRINCIPAL_INVESTIGATOR
References: