- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01880073
FemVue and Tubal Patency
Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
A thorough infertility evaluation commonly involves determining whether a woman's fallopian tubes are patent. The two most often utilized methods of evaluating the fallopian tubes are hysterosalpingogram (taking an X-ray of the pelvis after injecting dye through the uterus and fallopian tubes) and laparoscopic chromopertubation (a surgical procedure in which dye is visualized passing through the fallopian tubes).
The FemVue Saline-Air device is a new method of assessing tubal patency. The device utilizes a mixture of saline and air bubbles that can be seen passing through the fallopian tubes by ultrasound. FemVue can be efficiently performed in a physician's office and is minimally invasive. Unlike hysterosalpingogram and laparoscopic chromopertubation, it does not carry the risks of anesthesia or surgery, and doesn't expose the patient to radiation or contrast. It does, like the other two methods, carry a small risk of infection.
This study will involve using the FemVue device on patients under anesthesia in the operating room before they undergo scheduled laparoscopic chromopertubation, the gold standard for evaluating tubal patency. The two methods will be compared to determine the accuracy of the FemVue device.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.
Exclusion Criteria:
- Adnexal mass > 3.5cm or uterine size greater than 10 wks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FemVue device
FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.
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The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Who Had Concordant Findings
Time Frame: End of procedure, day 1.
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When the findings using the device was the same as the procedure.
In other words, if the device found tubes to be patent (open) and it was confirmed with the laparoscopic chromopertubation, the findings are said to be concordant the same as if the device found tubes to be blocked and the laparoscopic chromopertubation found the same.
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End of procedure, day 1.
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Number of Subjects With Discordant Findings
Time Frame: End of procedure, day 1.
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When the findings between the FemVue and Laparoscopic Chromopertubation were discordant, efficacy of FemVue was determined with a third procedure, a Hysterosalpingogram.
If the FemVue device found the tubes patent (open) and laparoscopic chromopertubation found them closed, the finding is considered discordant.
To determine which finding is accurate a third procedure was performed which is a Hysteropsalpingogram, another way to determine tubal patency.
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End of procedure, day 1.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.
Time Frame: 10 mins after start of procedure
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10 mins after start of procedure
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Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.
Time Frame: End of procedure, Day 1
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End of procedure, Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1202012213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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