RECRUITING

Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Conditions

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

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Official Title

Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Quick Facts

Study Start:2023-08-29
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05993546

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. * Patients with planned prone mini-PCNL and a preoperative NCCT
  2. * Primary stone size: 10-25 mm
  3. * Pre-existing indwelling nephrostomy tube or ureteral stent permitted
  4. * Age: ≥ 18 years old
  5. * Gender: all
  6. * Ethnicity: all
  7. * Capable of giving informed consent
  8. * Capable and willing to fulfill requirements of the study
  1. * Anticoagulated or history of coagulopathy
  2. * Congenital renal anomalies
  3. * Prior ipsilateral upper urinary tract reconstructive procedures
  4. * Conversion to open procedure
  5. * Multiple access tracts
  6. * Inability to give informed consent or unable to meet requirements of the study for any reason

Contacts and Locations

Study Contact

Marina Markovic
CONTACT
216-444-1152
MARKOVM@ccf.org

Principal Investigator

Sriharan Sivalingam
PRINCIPAL_INVESTIGATOR
Principal Investigator

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Sriharan Sivalingam, PRINCIPAL_INVESTIGATOR, Principal Investigator

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 Date2023-08-29
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-08-29
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Stone