Trial of Efficacy of the RetroPerc Device

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

The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy

Study Overview

• Status: Withdrawn
• Conditions: Kidney Stone
• Intervention / Treatment: Device: retrograde nephrostomy; Device: antegrade nephrostomy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography

Exclusion Criteria:

• Suspected pyelonephritis.
• Prior percutaneous nephrolithotomy procedure in affected kidney.
• Mid-ureteral or distal ureteral stones.
• Pregnancy.

• Anatomical abnormal kidney, including:

  • Horseshoe
  • Ectopic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (retrograde nephrostomy)	Device: retrograde nephrostomy; this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.
Active Comparator: Control Group ( antegrade nephrostomy)	Device: antegrade nephrostomy; this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access		end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation.		end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of access operation fluoroscopy		end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation		end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy		(end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by length of post-operative hospital stay		24 hours after procedure
Number of patients that are stone free	stone free is defined as <2mm on non-contrast computed tomography	6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of flank pain		6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,		6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work		6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.		6-12 weeks after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with nephrostomy access adequate for stone treatment		end of procedure( abut 3 hours from start of procedure)
Number of patients with normal vital signs		end of procedure( abut 3 hours from start of procedure)
Number of patients with normal laboratory values	laboratory values include complete metabolic panel and urinalysis	24 hours after procedure
Number of patients with an infection rate which is defined as a positive culture within the study time period		6-12 weeks after procedure
Number of patients that require pain medication (defined as discharge with an opioid prescription).		6-12 weeks after procedure

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Nadeem N Dhanani, MD,MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous nephrolithotomy (PCNL); nephrostomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi
• Other Study ID Numbers: HSC-MS-20-1269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No