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.

NCT06394752 | Recruiting FDA Device

• 1 other identifier: TD-1033
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Hysteroscopy; Hysteroscopy Technique; Fertility Issues; Uterus Abnormal; Gynecology; Visualization; Infertility Female

Keywords

hysteroscopy; fertility; gynecology; hydrosonography; uterine evaluation; uterine pathology

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Visual detection quality score (1-10)

  Captured during procedure

• Fluid used during distention

  Captured during procedure

• Pain during procedure

  Collected on day of procedure

• Adverse events rate

  Day of procedure and 24-48 hours post to procedure

Study Arms (2)

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.

Device: Visual Saline Infusion

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.

Device: Hydrosonography

Interventions

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).

Visual Saline Infusion

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.

Hydrosonography

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requiring a uterine cavity evaluation
• Premenopausal women between ages of 18-45

You may not qualify if:

• \. Positive test or history of any of the following conditions:
• a. Chlamydial pelvic infection
• b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place

Sponsors & Collaborators

• Center for Reproductive Health & Gynecology: lead
• Butterfly Biosciences, Inc: collaborator

Study Sites (2)

Center for Reproductive Health & Gynecology

Beverly Hills, California, 90007, United States

RECRUITING

Punta Mita Fertility Center

Corral Del Risco, Nayarit, 63734, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Infertility; Uterine Anomalies; Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Sam Najmabadi, MD

  Center for Reproductive Health & Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Nadal, MBA

CONTACT

323-420-6343; nadalalex@berkeley.edu

Sam Najmabadi, MD

CONTACT

310-360-7584; najmabadi@reproductive.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: April 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 30, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (1); ME (1)