Comparing two methods for detecting uterine problems in women.
UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
This study is testing a new device that lets doctors see inside the uterus to see if it works better than the usual method for finding uterine problems in women who can have babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Center for Reproductive Health & Gynecology Academic / other |
| Locations | 2 sites (Beverly Hills, California and 1 other locations) |
| Trial ID | NCT06394752 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a new Visual Saline Infusion Device (VSI) against standard Hydrosonography for identifying uterine pathologies in women of reproductive age. Participants will undergo both procedures to assess which method provides better diagnostic accuracy. The VSI device features a small catheter with a camera that allows for direct visualization of the uterus in an outpatient setting. The study will recruit up to 100 women from a fertility center in Los Angeles.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18-45 who require a uterine cavity evaluation.
Not a fit: Patients with a history of pelvic infections, positive pregnancy tests, or those currently using an IUD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of uterine evaluations, leading to better diagnosis and treatment of fertility issues.
How similar studies have performed: Other studies have shown promising results with similar diagnostic approaches, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beverly Hills, California and 1 other locations
- Center for Reproductive Health & Gynecology — Beverly Hills, California, United States (Recruiting)
- Punta Mita Fertility Center — Corral Del Risco, Nayarit, Mexico (Not_yet_recruiting)
Study contacts
- Principal investigator: Sam Najmabadi, MD — Center for Reproductive Health & Gynecology
- Study coordinator: Alexander Nadal, MBA
- Email: nadalalex@berkeley.edu
- Phone: 323-420-6343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.