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Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)

NCT07572227 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-07

No results posted yet for this study

Summary

The purpose of this research is to determine the feasibility and safety of performing fetal operative cystoscopy for the treatment of Lower Urinary Tract Obstruction (LUTO) using investigational devices.

Conditions

  • Lower Urinary Tract Obstruction, Congenital

Interventions

DEVICE

Fetal cystoscope

The fetoscope assembly includes the the Boston Scientific Maverick 2 balloon catheter and Emerge balloon, the Karl Storz Miniature Straight Forward Telescope, Operating Sheath, and connector. A fetal cystoscopy will be performed for treatment of lower urinary tract obstruction complicated by oligo/anhydramnios.

Sponsors & Collaborators

Principal Investigators

  • Mauro H. Schenone, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2056-03-23
Completion
2060-03-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT07572227 on ClinicalTrials.gov