HysteroscopyNCT06394752
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.
A study testing Visual Saline Infusion and Hydrosonography in people with Hysteroscopy and Hysteroscopy Technique, run by Center for Reproductive Health & Gynecology at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy, Hysteroscopy Technique, Fertility Issues
- What is being tested?
- Visual Saline Infusion and Hydrosonography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Apr 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients requiring a uterine cavity evaluation
- Premenopausal women between ages of 18-45
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Center for Reproductive Health & Gynecology
Beverly Hills, California, 90007
Spencer Wendt, 310-360-7584, info@reproductive.org
Sam Najmabadi, MD
Mexico1 site, 1 recruiting
- Not yet recruiting
Punta Mita Fertility Center
Corral del Risco, Nayarit, 63734
Jose Luis Rivas, MD, drrivas@puntamitahospital.com
Dr. Jose Luis Rivas, MD
About this study
Official title: UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
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.
Read the 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.
- Conditions
- Hysteroscopy, Hysteroscopy Technique, Fertility Issues, Uterus Abnormal, Gynecology, Visualization
- Being tested
- Visual Saline Infusion, Hydrosonography
- Keywords
- hysteroscopy, fertility, gynecology, hydrosonography, uterine evaluation, uterine pathology
- Medical subject headings
- Infertility, Uterine Anomalies, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Saline InfusionDevice
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).
HydrosonographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Hydrosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Procedure of approximately 2-5 minute duration
Secondary outcomes (4)
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.
Measured: Captured during procedure
Fluid used during distention
The volume of fluid used for distention of the uterus will be documented.
Measured: 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
Measured: Collected on day of procedure
Adverse events rate
Anticipated and unanticipated adverse events will be documented
Measured: Day of procedure and 24-48 hours post to procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start25 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Reproductive Health & Gynecology
- Sponsor type
- University, hospital or other
- Collaborators
- Butterfly Biosciences, Inc
- Responsible party
- Sponsor
- Investigators
- Sam Najmabadi, MD, Principal investigator, Center for Reproductive Health & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394752
- Sponsor's protocol ID
- TD-1033
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY
- ClinicalTrials.gov ID
- NCT06394752
- Acronym / sponsor ID
- TD-1033
- Conditions
- Hysteroscopy, Hysteroscopy Technique, Fertility Issues, Uterus Abnormal, Gynecology, Visualization
- Keywords
- hysteroscopy, fertility, gynecology, hydrosonography, uterine evaluation, uterine pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Center for Reproductive Health & GynecologyUniversity, hospital or other
- Collaborators
- Butterfly Biosciences, Inc
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Saline Infusion | Experimental | Device: Visual Saline InfusionVisual 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 | Device: HydrosonographyHydrosonography 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients requiring a uterine cavity evaluation
- Premenopausal women between ages of 18-45
Key exclusion criteria (3 listed)
- 1a. Chlamydial pelvic infection
- 1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Saline InfusionVisual 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). | Device | Visual Saline Infusion |
| HydrosonographyHydrosonography 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. | Device | Hydrosonography |
Primary outcome
Intrauterine pathology detection rate with Hydrosonography
Time frame: 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
Time frame: 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.
4 secondary outcomes
Visual detection quality score (1-10)
Time frame: Captured during procedure
Fluid used during distention
Time frame: Captured during procedure
Pain during procedure
Time frame: Collected on day of procedure
Adverse events rate
Time frame: Day of procedure and 24-48 hours post to procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Najmabadi, MD principal investigator
Center for Reproductive Health & Gynecology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Saline Infusion and Hydrosonography in people with Hysteroscopy and Hysteroscopy Technique, run by Center for Reproductive Health & Gynecology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nadal, MBA (323-420-6343, nadalalex@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine pathology detection rate with Hydrosonography (time frame: Procedure of 2-5 minute duration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.