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

Wright State University

Status: Terminated

Conditions: Contraception

Treatments: Device: HyCoSy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02628873

Lindheim2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Arm 1 (HyCoSy followed by HSG)

Experimental group

Description:

HyCoSy procedure followed by HSG procedure

Treatment:

Device: HyCoSy

Arm 2 (HSG followed by HyCoSy)

Experimental group

Description:

HSG procedure followed by HyCoSy procedure

Treatment:

Device: HyCoSy