FemVue and Tubal Patency

NCT01880073 | Terminated Results

• 1 other identifier: 1202012213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tubal Patency

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Who Had Concordant Findings

  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.

  End of procedure, day 1.

• Number of Subjects With Discordant Findings

  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.

  End of procedure, day 1.

Secondary Outcomes (2)

• 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

Study Arms (1)

FemVue device

EXPERIMENTAL

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

Device: FemVue device

Interventions

FemVue device 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 device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Limitations and Caveats

Limitations on study participants have precluded us from achieving statistically reliable results.

Results Point of Contact

• Title: Dr. Steven Spandorfer
• Organization: Center for Reproductive Medicine

sdspando@med.cornell.edu

646-962-3638

Study Officials

• Steven Spandorfer, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: June 18, 2013
• Study Start: May 1, 2012
• Primary Completion: May 24, 2016
• Study Completion: May 24, 2019
• Last Updated: May 27, 2020
• Results First Posted: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)