RECRUITING

RETRO Study (RETrograde Renal Access Outcomes)

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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 goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country. Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.

Official Title

RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device

Quick Facts

Study Start:2024-12-06

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07071831

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 Criteria	Exclusion Criteria
* Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size. * Age \>=18 years of age * Gender: both men and women included. * Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. * Plan for PCNL in the supine position	* Active pregnancy * BMI \>45 * Severe Hydronephrosis - renal pelvis diameter \> 20mm * Flank window \< 4 cm are ineligible for puncture * Previous ipsilateral PCNL * Currently with "useful" nephrostomy tube on ipsilateral side * Uncorrectable coagulopathies * Untreated urinary tract infection * Subjects with significant morbidities such as American Society of Anesthesiologists (ASA) score ≥ 4, severe spinal cord injuries, severe cardiopulmonary insufficiency, uncontrolled diabetes, neurological disorders, bedbound, anticipated life expectancy less than 5 years, or any other comorbidity, that in the opinion of the principal investigator could represent an increased peri-operative risk for the subject; * Ipsilateral partial nephrectomy * History of ipsilateral ureteral reimplantation or ureteral reconstruction; * History of Simple or radical prostatectomy * History of cystectomy * History of calyceal diverticula stone; * History of renal donation or transplant; * Any other previous pelvic surgical treatment that could put the subject at greater procedural complication risk or technical difficulty; * Ureteral ipsilateral stricture, untreated; * Ureteral stricture, untreated (not to include "tight" ureter); * Any other bladder, ureteral or kidney congenital genitourinary abnormalities (e.g. Horseshoe kidney, ipsilateral duplicated or partially duplicated collecting system, ipsilateral ectopic kidney, cross-fused ectopia, bifid renal pelvis with no horizontally directed calyces, solitary kidney, etc.) preventing the ability to direct a puncture laterally or render the subject stone free; * Have participated in any other clinical trial within the last 3 months, and/or plans to participate in any other investigational or invasive clinical trial during this study; * If female, breast-feeding, or if childbearing age, is not using contraception between screening and 90 days post-op; * Subject has current or recent history of substance abuse (e.g. recreational drugs, narcotics, or alcohol) requiring intervention; * Is a prisoner or ward of the state; * Is unable to meet the treatment and follow up protocol requirements.

Inclusion Criteria

Exclusion Criteria

* Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size.
* Age \>=18 years of age
* Gender: both men and women included.
* Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions.
* Plan for PCNL in the supine position

* Active pregnancy
* BMI \>45
* Severe Hydronephrosis - renal pelvis diameter \> 20mm
* Flank window \< 4 cm are ineligible for puncture
* Previous ipsilateral PCNL
* Currently with "useful" nephrostomy tube on ipsilateral side
* Uncorrectable coagulopathies
* Untreated urinary tract infection
* Subjects with significant morbidities such as American Society of Anesthesiologists (ASA) score ≥ 4, severe spinal cord injuries, severe cardiopulmonary insufficiency, uncontrolled diabetes, neurological disorders, bedbound, anticipated life expectancy less than 5 years, or any other comorbidity, that in the opinion of the principal investigator could represent an increased peri-operative risk for the subject;
* Ipsilateral partial nephrectomy
* History of ipsilateral ureteral reimplantation or ureteral reconstruction;
* History of Simple or radical prostatectomy
* History of cystectomy
* History of calyceal diverticula stone;
* History of renal donation or transplant;
* Any other previous pelvic surgical treatment that could put the subject at greater procedural complication risk or technical difficulty;
* Ureteral ipsilateral stricture, untreated;
* Ureteral stricture, untreated (not to include "tight" ureter);
* Any other bladder, ureteral or kidney congenital genitourinary abnormalities (e.g. Horseshoe kidney, ipsilateral duplicated or partially duplicated collecting system, ipsilateral ectopic kidney, cross-fused ectopia, bifid renal pelvis with no horizontally directed calyces, solitary kidney, etc.) preventing the ability to direct a puncture laterally or render the subject stone free;
* Have participated in any other clinical trial within the last 3 months, and/or plans to participate in any other investigational or invasive clinical trial during this study;
* If female, breast-feeding, or if childbearing age, is not using contraception between screening and 90 days post-op;
* Subject has current or recent history of substance abuse (e.g. recreational drugs, narcotics, or alcohol) requiring intervention;
* Is a prisoner or ward of the state;
* Is unable to meet the treatment and follow up protocol requirements.

Contacts and Locations

Study Contact

Research Program Manager

CONTACT

913-588-8721

jledesma2@kumc.edu

Principal Investigator

Bristol Whiles, MD

PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66105

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Bristol Whiles, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

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 Date2024-12-06

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-06

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

kidney stones

Additional Relevant MeSH Terms

Renal Stones