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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07572227
Status
Enrolling By Invitation

Conditions

  • Lower Urinary Tract Obstruction, Congenital

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetal cystoscope — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 23, 2056
Completion
Mar 23, 2060

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Fetal operative cystoscopy
    Patients pregnant with a male baby who has a lower urinary tract obstruction

Primary Outcome Measure

Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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