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| Name | Class |
|---|---|
| Butterfly Biosciences, Inc | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual Saline Infusion | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Saline Infusion | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Nadal, MBA | Contact | 323-420-6343 | nadalalex@berkeley.edu | |
| Sam Najmabadi, MD | Contact | 310-360-7584 | najmabadi@reproductive.org |
| Name | Affiliation | Role |
|---|---|---|
| Sam Najmabadi, MD | Center for Reproductive Health & Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproductive Health & Gynecology | Recruiting | Beverly Hills | California | 90007 | United States |
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|
| Hydrosonography | Device | 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. |
|
| Fluid used during distention | The volume of fluid used for distention of the uterus will be documented. | Captured during procedure |
| 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 |
| Adverse events rate | Anticipated and unanticipated adverse events will be documented | Day of procedure and 24-48 hours post to procedure |
| Punta Mita Fertility Center | Not yet recruiting | Corral del Risco | Nayarit | 63734 | Mexico |
|
| ID | Term |
|---|---|
| D007246 | Infertility |
| C562565 | Uterine Anomalies |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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