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Fetoscopy

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

N/A
Waitlist Available
Led By Rodrigo Ruano, MD
Research Sponsored by Rodrigo Ruano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male fetus with LUTO, dilated bladder, 'keyhole sign' and bilateral hydronephrosis
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post delivery
Awards & highlights

Study Summary

This trial looks at the outcomes of mothers and fetuses who receive treatment for a severe 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 LUTO, between 16 and nearly 26 weeks gestation. The fetus must have no chromosomal abnormalities or unrelated anomalies, and the mother should have favorable urine analysis results without prior in utero interventions. Women must not be at increased risk of preterm labor or have conditions that complicate surgery.Check my eligibility
What is being tested?
The study tests fetal cystoscopy outcomes on mothers and fetuses facing severe isolated LUTO at University of Miami/Jackson Health System. It involves using tiny instruments to view and potentially treat urinary blockages in the fetus during pregnancy.See study design
What are the potential side effects?
While specific side effects are not listed, fetal surgeries like cystoscopies can carry risks such as preterm labor, rupture of membranes, infection risks for both mother and child, bleeding complications, or potential harm to the fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My male fetus has a blocked urinary tract, swollen bladder, keyhole sign, and kidney swelling.
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My recent urine tests show low levels of sodium, chloride, and osmolality without any prior fetal treatments.
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My genetic tests show no chromosomal abnormalities.
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My karyotype is normal based on amniocentesis or CVS results.
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My family and I decided against ending the pregnancy before 24 weeks.
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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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 RuanoLead Sponsor
3 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Bladder Outlet Obstruction
10 Patients Enrolled for Bladder Outlet Obstruction
Rodrigo Ruano, MDPrincipal InvestigatorUniversity of Miami

Media Library

Fetal Cystoscopy (Fetoscopy) Clinical Trial Eligibility Overview. Trial Name: NCT05368727 — N/A
Bladder Outlet Obstruction Research Study Groups: Fetal Cystoscopy Group
Bladder Outlet Obstruction Clinical Trial 2023: Fetal Cystoscopy Highlights & Side Effects. Trial Name: NCT05368727 — N/A
Fetal Cystoscopy (Fetoscopy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368727 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting participants?

"Per the information hosted on clinicaltrials.gov, this research is no longer recruiting patients; it was initially posted on August 1st 2022 and last amended May 5th 202. Having said that, 7 other medical studies are currently looking for participants to join their trial."

Answered by AI
~6 spots leftby Aug 2027