Fertility Issues, Gynecology, Hysteroscopy, Hysteroscopy Technique, Infertility Female, Uterus Abnormal, Visualization
Conditions
Keywords
hysteroscopy, fertility, gynecology, hydrosonography, uterine evaluation, uterine pathology
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.
Interventions
DEVICEVisual 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).
DEVICEHydrosonography
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.
Sponsors
Butterfly Biosciences, Inc
Center for Reproductive Health & Gynecology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Fluid used during distention | Captured during procedure | The volume of fluid used for distention of the uterus will be documented. |
| 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 |
| Adverse events rate | Day of procedure and 24-48 hours post to procedure | Anticipated and unanticipated adverse events will be documented |
Countries
Mexico, United States
Contacts
Primary ContactAlexander Nadal, MBA
Backup ContactSam Najmabadi, MD
Outcome results
None listed