Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

NCT ID: NCT05022537

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.

Detailed Description

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Conditions

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Kidney Stone

Keywords

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nephrostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (retrograde nephrostomy)

Group Type EXPERIMENTAL

retrograde nephrostomy

Intervention Type DEVICE

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.

Control Group ( antegrade nephrostomy)

Group Type ACTIVE_COMPARATOR

antegrade nephrostomy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nadeem N Dhanani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadeem N Dhanani, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Nadeem N Dhanani, MD,MPH

Role: CONTACT

Phone: (713) 500-7337

Email: [email protected]

Amy Isidahomen

Role: CONTACT

Phone: 713-500-6086

Email: [email protected]

Facility Contacts

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Nadeem N Dhanani, MD,MPH

Role: primary

Amy Isidahomen

Role: backup

Other Identifiers

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HSC-MS-20-1269

Identifier Type: -

Identifier Source: org_study_id