NCT05022537

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

August 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
3.8 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

August 19, 2021

Last Update Submit

March 5, 2026

Conditions

Kidney Stone

Keywords

nephrostomyPercutaneous nephrolithotomy (PCNL)

Outcome Measures

Primary Outcomes (11)

  • 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 Outcomes (5)

  • 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

    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

Study Arms (2)

Treatment (retrograde nephrostomy)

EXPERIMENTAL
Device: retrograde nephrostomy

Control Group ( antegrade nephrostomy)

ACTIVE COMPARATOR
Device: antegrade nephrostomy

Interventions

retrograde nephrostomyDEVICE

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.

Treatment (retrograde nephrostomy)
antegrade nephrostomyDEVICE

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

Control Group ( antegrade nephrostomy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Suspected pyelonephritis.
  • Prior percutaneous nephrolithotomy procedure in affected kidney.
  • Mid-ureteral or distal ureteral stones.
  • Pregnancy.
  • Anatomical abnormal kidney, including:
  • Horseshoe
  • Ectopic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Nadeem N Dhanani, MD,MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 26, 2021

Study Start

July 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)