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

October 18, 2024 updated by: Wright State University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Wright State Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (HyCoSy followed by HSG)
HyCoSy procedure followed by HSG procedure
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
Other Names:
  • Fem Vue
  • Saline Air Device
  • Saline infused sonogram
Experimental: Arm 2 (HSG followed by HyCoSy)
HSG procedure followed by HyCoSy procedure
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
Other Names:
  • Fem Vue
  • Saline Air Device
  • Saline infused sonogram

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: 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)
At time of procedures
Physician Evaluation of Uterine Cavity
Time Frame: 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".
At time of HyCoSy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wright State University

Collaborators

Bayer

Investigators

  • Principal Investigator: Steven Lindheim, MD, Wright State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimated)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lindheim2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share date due to small sample size

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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