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NCT01548196 · ClinicalTrials.gov registry record · Phase 3
Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
A Phase 3 study of Nephrolithotomy, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01548196 is a Phase 3 study of Nephrolithotomy that has completed, run by Duke University. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01548196, a Phase 3 study of Nephrolithotomy, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.
Conditions Studied
Interventions
- PROCEDURE Standard Percutaneous nephrolithotomy
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01548196
The ClinicalTrials.gov registry entry for NCT01548196 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nephrolithotomy appearing as the primary indexed condition, and to 1 intervention - of which Standard Percutaneous nephrolithotomy is the first listed.
NCT01548196 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01548196 about?
NCT01548196 is a clinical study titled "Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL". The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, ...
What is the current status of trial NCT01548196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2008-02. Estimated completion is 2011-09.
What conditions does trial NCT01548196 study?
This clinical trial studies the following conditions: Nephrolithotomy.
What interventions are being tested in trial NCT01548196?
The interventions under investigation include: Standard Percutaneous nephrolithotomy (PROCEDURE).
Who is sponsoring clinical trial NCT01548196?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01548196 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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