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Pediatric Robotic Versus Open Pyeloplasty

NCT04884945 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-06-06

Study results available
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Summary

The objective is conduct a pilot randomized controlled trial comparing robotic and open techniques for surgical correction of congenital UPJ obstruction (pyeloplasty) in pediatric patients. This study will serve as a proof of concept trial to demonstrate feasibility of recruiting pediatric patients to participate in a randomized study for surgical procedures and delineate patient-centered outcomes. Should this study prove randomization is feasible, a randomized comparative effectiveness trial with sufficient power to determine whether open or robotic-assisted pyeloplasty has superior patient-centered outcomes will be pursued.

Conditions

  • Pediatric Urology
  • Ureteropelvic Junction Obstruction

Interventions

PROCEDURE

Open Pyeloplasty (OP)

Open approach for the surgical correction of UPJ obstruction

DEVICE

Robotic-Assisted Laparoscopic Pyeloplasty (RALP)

Robotic approach with the da Vinci Surgical System for the surgical correction of UPJ obstruction

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Benjamin Whittam, MD · Riley Children's Health, Indiana University Health, Pediatric Urology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2019-11-14
Completion
2021-06-23
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 NCT04884945 on ClinicalTrials.gov