FemVue and Tubal Patency

Not Applicable

Terminated

• Conditions: Tubal Patency
• Interventions: Device: FemVue device

• Registration Number: NCT01880073
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Subjects who agree to participate will have their tubes evaluated by using the FemVue Saline-Air device and laparoscopic chromopertubation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Primary Completion: 2016-05-24
• Study Completion: 2019-05-24
• Status Verified: 2020-05
• Results First Submitted: 2020-05-14
• Results First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Results First Posted: 2020-05-27
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Pts ages 18-45 undergoing planned diagnostic laparoscopy with chromopertubation.

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Exclusion Criteria

• Adnexal mass > 3.5cm or uterine size greater than 10 wks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FemVue device	FemVue device	FemVue would be used in conjunction with the laparoscopic chromopertubation to determine if it is as effective.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Discordant Findings	End of procedure, day 1.	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.
Number of Subjects Who Had Concordant Findings	End of procedure, day 1.	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.

Secondary Outcome Measures

Name	Time	Method
The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device.	10 mins after start of procedure
Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation.	End of procedure, Day 1

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States