Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Part of paid clinical trials in Miami, Florida.

Sponsor
Rodrigo Ruano
Study ID
NCT03281798
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

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

Interventions

  • Fetoscopes — DEVICE
    Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
  • Fetal Cystoscopy — PROCEDURE
    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.

Study Details

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).

Key Dates

Start date
Jan 1, 2018
Status verified
Feb 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

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

Arms

  • Experimental: Fetal Cystoscopy Group
    Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.

Primary Outcome Measure

Number of participants where the procedure was technically performed [ Time Frame: Day 1 (Post fetal cystoscopy procedure) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Rodrigo Ruano, MD, Ph.D
[email protected]
305-243-0769
Rodrigo Ruano (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-

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By research site
University of Miami· Miami, FLMayo Clinic· Rochester, MN

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