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Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (CYSTO Trial)
CYSTO Trial Summary
This trial looks at how safe and effective it is to do surgery on the fetus to relieve a blockage in the urinary tract.
CYSTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCYSTO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CYSTO Trial Design
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Who is running the clinical trial?
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- I cannot have fetoscopic surgery due to conditions like uterine fibroids or anomalies.You have too little or no amniotic fluid in the womb.I do not have HIV or Hepatitis, or I have tested negative for them.I don't have insurance for routine clinical care including prenatal and delivery services.You have placental issues like previa, abruption, or accreta.You have a high chance of giving birth too early, including having a short cervix or a history of giving birth too early.You have a condition related to blood type that could affect the current pregnancy.I have a health condition that makes surgery or anesthesia unsafe for me.My recent urine tests show low levels of sodium, chloride, and osmolality.The pregnancy is between 16 and 25 weeks along when the procedure is done.My family and I decided against ending the pregnancy before 24 weeks.I cannot have surgery due to a previous cut in my uterus.My unborn baby has a condition not related to lower urinary tract obstruction.I was born with a heart defect.My male fetus has a urinary tract obstruction and kidney swelling.My genetic test results from amniocentesis or CVS are normal.My genetic tests show no chromosomal abnormalities.My unborn baby is female.I am 18 years old or older.I choose not to undergo invasive tests.Your family does not meet the emotional and social requirements.
- Group 1: Fetal Cystoscopy Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are participating in this clinical experiment?
"Affirmative, the clinicaltrials.gov registry shows that this trial is actively enrolling participants - which began on January 1st of 2018 and was most recently updated on September 14th 2022. Ten individuals are needed to take part in the research between 2 locations."
Are any individuals currently being enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov exhibits that this research is currently recruiting participants, having first been published on January 1st 2018 and most recently updated September 14th 2022. The investigation calls for 10 individuals to take part at two different sites."
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