TerminatedNot Applicable

Early Infancy Ureteral Reimplantation for Distal Ureteral Obstruction

Stopped: Principal investigator is moving to a different institution.

United States5 participantsStarted 2015-05-22

Plain-language summary

Prospective multicenter observational study of early infancy ureteral reimplantation for distal ureteral obstruction. The study is an observation study since the investigators will not assign specific interventions to the subjects of the study. The purpose of the study is to describe the surgical outcomes of early infancy ureteral reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no other urologic pathologic and a normal contralateral kidney who have been recommended a ureteral reimplant by their pediatric urologist are eligible for the study. Patients that consent for the study will be prospectively followed for 1 year to record the outcomes of the surgery.

Who can participate

Age range

6 Months

Sex

ALL

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: * Children younger 6 months of age who have been recommended by their urologist to have a unilateral ureteral reimplant. * Unilateral obstructive disease (as defined by the BAPU) * Ipsilateral Single system * Ipsilateral VUR is ok * Contralateral reflux grades 1-3 ok as long as the reflux will be observed Exclusion criteria * Duplicated systems * First Febrile UTI's and megaureter or ectopic ureter but no evidence of obstruction or loss of function * Neurogenic bladder, valves * Contralateral reflux grade 4-5

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

Reoperation

Timeframe: 1 year

Trial details

NCT IDNCT02419339

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06-04

View on ClinicalTrials.gov More Ureteral Obstruction trials