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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06394752
Other study ID # TD-1033
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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