Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement
NCT ID: NCT02628873
Last Updated: 2024-10-22
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
21 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-12-31
Study Completion Date
2018-10-31
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.
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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.
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
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Contraception
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Cross over study in which participants receive one diagnostic test (SSI or HSG), then receive the other.
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
SINGLE
Outcome Assessors
Outcomes assessor does not know which procedure was received first or second.
Study Groups
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Arm 1 (HyCoSy followed by HSG)
HyCoSy procedure followed by HSG procedure
Group Type
EXPERIMENTAL
HyCoSy
Intervention Type
DEVICE
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
Arm 2 (HSG followed by HyCoSy)
HSG procedure followed by HyCoSy procedure
Group Type
EXPERIMENTAL
HyCoSy
Intervention Type
DEVICE
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
Interventions
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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
Intervention Type
DEVICE
Other Intervention Names
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Fem Vue
Saline Air Device
Saline infused sonogram
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
* 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.
* History of a hysterectomy.
* Current urogenital disease.
* History of allergic response to IVP dye (exclusion for HSG).
* Abnormal pap smear.
* Positive urine pregnancy test.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Bayer
INDUSTRY
Sponsor Role
collaborator
Wright State University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven Lindheim, MD
Role: PRINCIPAL_INVESTIGATOR
Wright State University
Locations
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Wright State Physicians
Dayton, Ohio, United States
Site Status
Countries
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United States
References
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Luong E, Ludwin A, Winter T, Yaklic J, Maxwell RA, Bhagavath B, Lindheim SR. Saline-Air Hysterosalpingo-Contrast Sonography Is Equivalent to the Modified Hysterosalpingogram Following Hysteroscopic Sterilization. Ultrasound Q. 2020 Jun;36(2):138-145. doi: 10.1097/RUQ.0000000000000488.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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Lindheim2015-01
Identifier Type: -
Identifier Source: org_study_id
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