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.
NCT ID: NCT06394752
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-04-25
2025-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Premenopausal women between ages of 18-45
Exclusion Criteria
1a. Chlamydial pelvic infection
1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place
18 Years
55 Years
FEMALE
Yes
Sponsors
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Butterfly Biosciences, Inc
UNKNOWN
Center for Reproductive Health & Gynecology
OTHER
Responsible Party
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Principal Investigators
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Sam Najmabadi, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Reproductive Health & Gynecology
Locations
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Center for Reproductive Health & Gynecology
Beverly Hills, California, United States
Punta Mita Fertility Center
Corral Del Risco, Nayarit, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TD-1033
Identifier Type: -
Identifier Source: org_study_id
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