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

Q: How many individuals are participating in this clinical experiment?

<p>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.</p>

Q: Are any individuals currently being enrolled in this clinical experiment?

<p>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.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post delivery

Awards & highlights

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.

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.Check my eligibility

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.See study design

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.

CYSTO Trial 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.

CYSTO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post delivery

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

CYSTO 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.

0 / 6Eligibility criteria met

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

1 Trials studying Bladder Outlet Obstruction

9 Patients Enrolled for Bladder Outlet Obstruction

Rodrigo Ruano, M.D., Ph.D.Principal InvestigatorMayo Clinic

1 Previous Clinical Trials

10 Total Patients Enrolled

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

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Rodrigo Ruano 2018. "Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03281798.

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