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

Not Applicable

Terminated

• Conditions: Contraception
• Interventions: Device: HyCoSy

• Registration Number: NCT02628873
• Lead Sponsor: Wright State University

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-05
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2018-09
• Study Completion: 2018-10
• Results First Submitted: 2019-12-13
• Results First Submitted QC: 2020-08-22
• Results First Posted: 2020-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1 (HyCoSy followed by HSG)	HyCoSy	HyCoSy procedure followed by HSG procedure
Arm 2 (HSG followed by HyCoSy)	HyCoSy	HSG procedure followed by HyCoSy procedure

Primary Outcome Measures

Name	Time	Method
Fallopian Tube Patency - HyCoSy vs HSG	At time of procedure	Observed flow of fluid/bubbles through fallopian tubes.

Secondary Outcome Measures

Name	Time	Method
Physician Evaluation of Uterine Cavity	At time of HyCoSy procedure	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".
Pain Scores	At time of procedures	Patient reported pain scale score on visual pain scale (rated 0 for no pain to 10 for severe pain with corresponding faces)

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Dayton, Ohio, United States