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Fetal Cystoscopy for Lower Urinary Tract Obstruction

NCT02446184 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-02-13

No results posted yet for this study

Summary

This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to the investigators clinical experience with fetal vesicoamniotic shunting.

Conditions

  • Urethral Obstruction

Interventions

PROCEDURE

Fetal Cystoscopy

Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.

PROCEDURE

Fetal vesicoamniotic shunt

Fetal vesicoamniotic shunt will be performed under ultrasound guidance

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Michael A Belfort, MD, PhD · Baylor College of Medicine

  • Rodrigo Ruano, MD, PhD · Baylor Colleg of Medicine (Previously); Mayo Clinic (currently)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Weeks
Max Age
26 Weeks
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-04
Primary Completion
2016-08-31
Completion
2016-08-23

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 NCT02446184 on ClinicalTrials.gov