RECRUITING

Occlusion Balloon vs. 5FR Ureteral Catheter

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).

Official Title

The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter

Quick Facts

Study Start:2025-01-23
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06798753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 years and older.
  2. * Diagnosed with kidney stones and scheduled for PCNL.
  3. * Able and willing to provide informed consent.
  1. * Pregnant women
  2. * Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum.
  3. * Prone procedure

Contacts and Locations

Study Contact

Blair Gallante, MPH
CONTACT
631-991-1159
blair.gallante@mountsinai.org
Mantu Gupta, MD
CONTACT
212-241-1272
mantu.gupta@mountsinai.org

Principal Investigator

Mantu Gupta, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai West
New York, New York, 10019
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Mantu Gupta, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • percutaneous nephrolithotomy
  • PCNL
  • Occlusion Balloon Catheter
  • kidney stone

Additional Relevant MeSH Terms

  • Kidney Stones