RecruitingNot ApplicableNCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial


Sponsor

Rodrigo Ruano

Enrollment

10 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates fetal cystoscopy, a minimally invasive procedure performed during pregnancy, to treat a serious blockage in a male baby's urinary tract called lower urinary tract obstruction (LUTO). Left untreated, this condition can severely damage the baby's kidneys and lungs. You may be eligible if: - You are a pregnant woman aged 18 or older carrying a single male fetus - Your baby has been diagnosed with LUTO showing a blocked bladder and reduced amniotic fluid - Your baby's urine tests show kidneys may still be salvageable - Your baby has no chromosomal abnormalities - You are between 16 and 26 weeks pregnant at the time of the procedure - You have considered and declined termination - You have adequate social support and health insurance for follow-up care You may NOT be eligible if: - Your baby has other abnormalities unrelated to LUTO, or has a heart defect - You are at high risk for preterm labor (short cervix, prior preterm birth) - You have placental complications (previa, abruption, accreta) - You are HIV positive, or Hepatitis B or C positive - You have a medical condition that makes surgery or anesthesia unsafe for you - You are unable to travel and comply with follow-up requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFetoscopes

Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.

PROCEDUREFetal Cystoscopy

A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.


Locations(2)

University of Miami

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

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NCT03281798


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