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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
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)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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. FemVue vs. laparoscopic chromopertubation [ Time Frame: 2 weeks. ]
    To evaluate the efficacy of the FemVue Saline-Air device as compared to laparoscopic chromopertubation.

  2. 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.



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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


Contacts
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Contact: Mitasha C. Joseph, RN, MPA 646-962-3382 mij2008@med.cornell.edu
Contact: Rodriq E. Stubbs, NP 646-962-3276 res2011@med.cornell.edu

Locations
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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    mij2008@med.cornell.edu   
Contact: Rodriq E. Stubbs, NP    646-962-3276    res2011@med.cornell.edu   
Principal Investigator: Glenn Schattman, MD         
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     History of Changes
Other Study ID Numbers: 1202012213
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No