FemVue and Tubal Patency
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|ClinicalTrials.gov Identifier: NCT01880073|
Recruitment Status : Recruiting
First Posted : June 18, 2013
Last Update Posted : January 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Tubal Patency||Device: FemVue device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: FemVue device
FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.
Device: FemVue device
The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.
- FemVue vs. laparoscopic chromopertubation [ Time Frame: 2 weeks. ]To evaluate the efficacy of the FemVue Saline-Air device as compared to laparoscopic chromopertubation.
- Tubal patency [ Time Frame: 1 day ]The device utilizes a mixture of saline and air to create "scintillations" or echogenic air bubbles, which , after passing through the intrauterine catheter, can be visualized by ultrasound passing from the endometrial cavity through the length of each fallopian tube into the peritoneal cavity. Using a transvaginal ultrasound, if air bubbles are seen to flow through the length of the fallopian tube and into the peritoneal cavity, tubal patency is documented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880073
|Contact: Mitasha C. Joseph, RN, MPAfirstname.lastname@example.org|
|Contact: Rodriq E. Stubbs, NPemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mitasha C Joseph, RN, MPA 646-962-3382 firstname.lastname@example.org|
|Contact: Rodriq E. Stubbs, NP 646-962-3276 email@example.com|
|Principal Investigator: Glenn Schattman, MD|
|Principal Investigator:||Steven Spandorfer, MD||Weill Medical College of Cornell University|