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FemVue and Tubal Patency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880073
Recruitment Status : Terminated (Slow recruitment)
First Posted : June 18, 2013
Results First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Tubal Patency Device: FemVue device Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of FemVue for Assessment of Tubal Patency as Compared to Laparoscopic Chromopertubation
Actual Study Start Date : May 2012
Actual Primary Completion Date : May 24, 2016
Actual Study Completion Date : May 24, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Subjects Who Had Concordant Findings [ Time Frame: 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.

  2. Number of Subjects With Discordant Findings [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Time Frame in Which Patency of the Tubes Was Determined With the FemVue Device. [ Time Frame: 10 mins after start of procedure ]
  2. Time Frame in Which Patency of the Tubes Was Determined by Laparoscopic Chrompertubation. [ Time Frame: End of procedure, Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Steven Spandorfer, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01880073    
Other Study ID Numbers: 1202012213
First Posted: June 18, 2013    Key Record Dates
Results First Posted: May 27, 2020
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No