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 range

18 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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