NCT03526458 is a NA clinical trial of Holmium:YAG laser in Stone Ureter, sponsored by University of Wisconsin, Madison.

Who is sponsoring NCT03526458?

NCT03526458 is sponsored by University of Wisconsin, Madison.

What drugs are being tested in NCT03526458?

Interventions in NCT03526458: Holmium:YAG laser.

What condition does NCT03526458 study?

NCT03526458 studies Stone Ureter, Stone;Renal, Surgery.

Is NCT03526458 still recruiting?

NCT03526458 is currently completed. Last updated 20 September 2021.

Are results published for NCT03526458?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-20 · How we verify

NCT03526458

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones

Completed NA Results posted Last updated 20 September 2021

What this trial tests

NA trial testing Holmium:YAG laser in Stone Ureter in 40 participants. Completed in 24 March 2021.

Timeline

30 July 2019

Primary endpoint
24 March 2021

24 March 2021

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	30 July 2019
Primary completion	24 March 2021
Estimated completion	24 March 2021
Sites	1 location across United States

Drugs / interventions tested

Holmium:YAG laser

Conditions studied

Stone Ureter — all drugs for Stone Ureter →
Stone;Renal — all drugs for Stone;Renal →
Surgery — all drugs for Surgery →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Stone Ureter or Stone;Renal. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fragmentation Time Primary · up to 6 hours

The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	24.5	± 19.2
Holmium:YAG Laser: 0.8J&15Hz	7.9	± 3.2

Total Operative Time Secondary · up to 6 hours

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	75.7	± 20.6
Holmium:YAG Laser: 0.8J&15Hz	64.3	± 17.2

Pre-Operative Stone Size Secondary · Retrospective review of health chart at Baseline

Pre-operative stone size (on pre-operative CT) will be reported in millimeters.

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	11.2	± 5.2
Holmium:YAG Laser: 0.8J&15Hz	9.2	± 8.2

Number of Participants With Either Ureteral or Renal Location of Urinary Stone Secondary · up to 6 hours

Urinary stone location will be classified as renal or ureter.

Ureteral

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	8
Holmium:YAG Laser: 0.8J&15Hz	7

Renal

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	4
Holmium:YAG Laser: 0.8J&15Hz	8

Number of Participants Treated for Either Single or Multiple Urinary Stones Secondary · up to 6 hours

Single

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	8
Holmium:YAG Laser: 0.8J&15Hz	14

Multiple

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	4
Holmium:YAG Laser: 0.8J&15Hz	1

Density of Urinary Stones Secondary · up to 6 hours

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	935.2	± 367.9
Holmium:YAG Laser: 0.8J&15Hz	924.7	± 374.5

Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm Secondary · up to 6 hours

Size of fragments created will be assessed using the laser fiber size as a comparison.

1mm

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	1
Holmium:YAG Laser: 0.8J&15Hz	5

2mm

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	10
Holmium:YAG Laser: 0.8J&15Hz	10

3mm

Group	Value	95% CI
Holmium:YAG Laser: 0.2J&15Hz	1
Holmium:YAG Laser: 0.8J&15Hz	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Stone Ureter

Currently open trials in the same condition.

NCT07068087 — Silodosin in Facilitating Flexible Uretroscopy · NA · active not recruiting
NCT06728943 — Efficacy of Intra-Ureteric Aminophylline Installation After Failed Stone Accessibility by Semi-rigid Ureteroscopy. Prosp · NA · recruiting
NCT06819553 — A Randomized Clinical Trial to Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrust · Phase 2, PHASE3 · active not recruiting
NCT05866081 — Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative · NA · recruiting

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

NCT07440004 — Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts · Phase 1 · recruiting
NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
NCT07470723 — The ORIGIN-FH Study · NA · recruiting
NCT06975657 — Well-being Skills for Reentry · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03526458 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 20 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03526458.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing