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NCT03526458 · ClinicalTrials.gov registry record · NA
Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
A NA study of Surgery and Stone Ureter, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03526458: Completed NA study of Surgery and Stone Ureter, sponsored by University of Wisconsin, Madison.
NCT03526458 is a NA study of Surgery and Stone Ureter that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 40 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526458, a NA study of Surgery and Stone Ureter, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones. The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size. This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014. Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time. In this study, the frequency is set at 15Hz. Thus, the study contains two arms: 0.2J\&15Hz, and 0.8J\&15Hz. Patients will be randomized into the two groups by the ratio of 1:1.
Primary Outcome
The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
Conditions Studied
Interventions
- DEVICE Holmium:YAG laser
Study Locations (1)
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2021-03-24 |
| Phase | NA |
What the finished NCT03526458 record still lists
NCT03526458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention - of which Holmium:YAG laser is the first listed.
NCT03526458 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03526458 about?
NCT03526458 is a clinical study titled "Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones". The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J. The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragment...
What is the current status of trial NCT03526458?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-07-30. Estimated completion is 2021-03-24.
What conditions does trial NCT03526458 study?
This clinical trial studies the following conditions: Surgery, Stone Ureter, Stone;Renal.
What interventions are being tested in trial NCT03526458?
The interventions under investigation include: Holmium:YAG laser (DEVICE).
Who is sponsoring clinical trial NCT03526458?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03526458 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03526458's enrollment target sits among peer trials
40 100th of 120 higher than 19 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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