NCT03526458

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 20, 2021

Completed
Last Updated

September 20, 2021

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

November 14, 2017

Results QC Date

July 27, 2021

Last Update Submit

August 24, 2021

Conditions

Stone UreterStone;RenalSurgery

Keywords

Holmium LaserLaser settingStone fragmentation

Outcome Measures

Primary Outcomes (1)

  • Fragmentation Time

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

    up to 6 hours

Secondary Outcomes (6)

  • Total Operative Time

    up to 6 hours

  • Pre-Operative Stone Size

    Retrospective review of health chart at Baseline

  • Number of Participants With Either Ureteral or Renal Location of Urinary Stone

    up to 6 hours

  • Number of Participants Treated for Either Single or Multiple Urinary Stones

    up to 6 hours

  • Density of Urinary Stones

    up to 6 hours

  • +1 more secondary outcomes

Study Arms (2)

Holmium:YAG laser: 0.2J&15Hz

ACTIVE COMPARATOR

Patients are assigned to treat stones with 0.2J\&15Hz of the holmium laser.

Device: Holmium:YAG laser

Holmium:YAG laser: 0.8J&15Hz

EXPERIMENTAL

Patients are assigned to treat stones with 0.8J\&15Hz of the holmium laser.

Device: Holmium:YAG laser

Interventions

Holmium:YAG laserDEVICE

Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)

Holmium:YAG laser: 0.2J&15HzHolmium:YAG laser: 0.8J&15Hz

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at least 18 years of age
  • Patients with urinary stones who require endoscopic treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

UreterolithiasisNephrolithiasis

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesKidney Diseases

Results Point of Contact

Title
Shuang Li
Organization
University of Wisconsin, School of Medicine and Public Health, Department of Urology
lis@urology.wisc.edu
6082638336

Study Officials

  • Stephen Nakada, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

May 16, 2018

Study Start

July 30, 2019

Primary Completion

March 24, 2021

Study Completion

March 24, 2021

Last Updated

September 20, 2021

Results First Posted

August 20, 2021

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)