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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Device: HyCoSy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documentation of normal Pap smear within 1 year prior to enrollment into study. Written informed consent given Need for evaluation of tubal status for post-Essure tubal occlusion Negative urine pregnancy test Exclusion Criteria: History of unresolved dysfunctional uterine bleeding (DUB). History of a hysterectomy. Current urogenital disease. History of allergic response to IVP dye (exclusion for HSG). Abnormal pap smear. Positive urine pregnancy test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (HyCoSy followed by HSG)<br>HyCoSy procedure followed by HSG procedure | Device: HyCoSy<br>* 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<br>* Other names: Saline infused sonogram;|
| Experimental: Arm 2 (HSG followed by HyCoSy)<br>HSG procedure followed by HyCoSy procedure | Device: HyCoSy<br>* 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<br>* Other names: Saline infused sonogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fallopian Tube Patency - HyCoSy vs HSG | Observed flow of fluid/bubbles through fallopian tubes. | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces) | At time of procedures | 
| Physician Evaluation of Uterine Cavity | Observed image of uterus (normal or not normal). Assessor commented on uterine cavity to determine whether cavity was normal versus abnormal, e.g., bicornuate uterus or any notable uterine deformity. Data were coded as normal' or not normal. | At time of HyCoSy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSG, HyCoSy, Contraception, Essure, Saline Infused sonography, SIS, Air bubbles