TerminatedNot Applicable

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

Stopped: Essure no longer sold in the US after Dec 2018; Sponsor requested trial be ended

United States21 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Fallopian Tube Patency - HyCoSy vs HSG

Timeframe: At time of procedure

Trial details

NCT IDNCT02628873

SponsorWright State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2019-12-13

View on ClinicalTrials.gov More Contraception trials