N/A
Completed N=40
Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
Stone Ureter · Stone;Renal · Surgery
Source: ClinicalTrials.gov NCT03526458 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Fragmentation Time — 24.5; 7.9 Minutes — p=0.012
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fragmentation Time |
24.5; 7.9 | 0.012 sig |
| SECONDARY Total Operative Time |
75.7; 64.3 | 0.132 |
| SECONDARY Pre-Operative Stone Size |
11.2; 9.2 | 0.654 |
| SECONDARY Number of Participants With Either Ureteral or Renal Location of Urinary Stone |
8; 7; 4; 8 | 0.299 |
| SECONDARY Number of Participants Treated for Either Single or Multiple Urinary Stones |
8; 14; 4; 1 | 0.076 |
| SECONDARY Density of Urinary Stones |
935.2; 924.7 | 0.943 |
| SECONDARY Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm |
1; 5; 10; 10; 1; 0 | 0.185 |
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age
- Patients with urinary stones who require endoscopic treatment
Exclusion Criteria
- Patients < 18 years of age
- Pregnant patients
- Pre-menopausal females who have not been on approved birth control for at least 1 month pre-operatively
- Patients with stones known to be refractory to treatment with the holmium laser
Data sourced from ClinicalTrials.gov (NCT03526458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.