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Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (CYSTO Trial)

N/A
Recruiting
Led By Rodrigo Ruano, M.D., Ph.D.
Research Sponsored by Rodrigo Ruano M.D., Ph.D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy)
Family have considered and declined the option of termination of the pregnancy at less than 24 weeks
Must not have
Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post delivery
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for pregnant women over 18 with a male fetus diagnosed with severe lower urinary tract obstruction (LUTO). The fetus must show specific signs on ultrasound, have favorable urine analysis results, and no chromosomal abnormalities. Gestational age should be between 16-25 weeks. Women must not have medical or pregnancy-related risks that could complicate surgery.
What is being tested?
The study tests fetal cystoscopy using fetoscopes to treat severe LUTO in unborn males. It aims to evaluate the outcomes of this prenatal intervention compared to standard care, focusing on both maternal and fetal health after the procedure.
What are the potential side effects?
While specific side effects are not listed here, interventions like fetal cystoscopy can carry risks such as preterm labor, infection risk for mother and baby, potential injury during surgery, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My recent urine tests show low levels of sodium, chloride, and osmolality.
Select...
My family and I decided against ending the pregnancy before 24 weeks.
Select...
My male fetus has a urinary tract obstruction and kidney swelling.
Select...
My genetic test results from amniocentesis or CVS are normal.
Select...
My genetic tests show no chromosomal abnormalities.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have fetoscopic surgery due to conditions like uterine fibroids or anomalies.
Select...
I do not have HIV or Hepatitis, or I have tested negative for them.
Select...
I have a health condition that makes surgery or anesthesia unsafe for me.
Select...
I cannot have surgery due to a previous cut in my uterus.
Select...
My unborn baby has a condition not related to lower urinary tract obstruction.
Select...
I was born with a heart defect.
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My unborn baby is female.
Select...
I choose not to undergo invasive tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants where the etiology of LUTO was correctly diagnosed
Number of participants where the posterior urethral valve were successfully released
Number of participants where the procedure was technically performed
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fetal Cystoscopy GroupExperimental Treatment2 Interventions
Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.

Find a Location

Who is running the clinical trial?

Rodrigo Ruano M.D., Ph.DLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Rodrigo RuanoLead Sponsor
3 Previous Clinical Trials
29 Total Patients Enrolled
Rodrigo Ruano, M.D., Ph.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled
Rodrigo Ruano, MD, PhD.Principal InvestigatorUniversity of Miami

Media Library

Fetal Cystoscopy Clinical Trial Eligibility Overview. Trial Name: NCT03281798 — N/A
Bladder outlet obstruction Research Study Groups: Fetal Cystoscopy Group
Bladder outlet obstruction Clinical Trial 2023: Fetal Cystoscopy Highlights & Side Effects. Trial Name: NCT03281798 — N/A
Fetal Cystoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03281798 — N/A
~3 spots leftby Aug 2027
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