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Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

NCT03281798 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-24

No results posted yet for this study

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).

Conditions

  • Lower Urinary Tract Obstructive Syndrome
  • Lower Urinary Tract Obstruction, Congenital
  • Bladder Outlet Obstruction
  • Bladder Outflow Obstruction

Interventions

DEVICE

Fetoscopes

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

PROCEDURE

Fetal 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.

Sponsors & Collaborators

  • Rodrigo Ruano

    lead OTHER

Principal Investigators

  • Rodrigo Ruano, MD, PhD. · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2028-08-01
Completion
2028-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281798 on ClinicalTrials.gov