NCT02628873

Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement

Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Wright State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.

Detailed description

The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes. However, this procedure involved exposure to radiation. The saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve radiation and can be done in a physician's office. The HyCoSy air bubble device may be a lower cost, safer alternative procedure if it can be shown to provide similar results for tubal patency. This study will compare the HyCoSy procedure results with the HSG procedure results in women who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure confirmation test. Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure or to the reverse order. Two independent readers will review the video results for both procedures to determine the degree of agreement on tubal patency.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	HyCoSy	Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2015-12-11
• Last updated: 2024-10-22
• Results posted: 2020-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study