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 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.

Study Overview

• Status: Completed
• Conditions: Surgery; Stone Ureter; Stone;Renal
• Intervention / Treatment: Device: Holmium:YAG laser

Detailed Description

The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (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. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.

The study procedures are:

1. A study team member who is affiliated with the patient's clinical care (e.g., the surgeon) will initially approach the patients who are scheduled laser lithotripsy treatment of urinary stones. (i.e. informed that there's a research study they may be eligible for, and asked if they want to learn more about it).
2. If the patient is interested in the study, a member of the research team will approach him/her for enrollment.
3. Once the consent form is obtained, patients' medical background will be reviewed for inclusion/exclusion criteria. Patients who meet the inclusion criteria will be included in the study; patients who do not meet the inclusion criteria will be excluded.
4. Patients will be randomized to either 0.2J&15Hz or 0.8J&15Hz (randomization ratio 1:1) group.
5. Patients will undergo stone surgeries with the laser setting that they are randomized to. The patient's stone(s) will be treated in accordance with the routine clinical practice of fragmenting stone into small pieces (≤ 2mm). The faculty surgeon (i.e., Dr. Nakada) will perform all surgeries.
6. Fragmentation time as well as other information (total surgery time, complications, stone information, and number of stones treated) is collected.
7. After surgery, the patients will then continue on normal postoperative pathway. Postoperative complications will be collected.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Holmium:YAG laser: 0.2J&15Hz; Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.	Device: Holmium:YAG laser; 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)
Experimental: Holmium:YAG laser: 0.8J&15Hz; Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.	Device: Holmium:YAG laser; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fragmentation Time	The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)	up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Operative Time		up to 6 hours
Pre-Operative Stone Size	Pre-operative stone size (on pre-operative CT) will be reported in millimeters.	Retrospective review of health chart at Baseline
Number of Participants With Either Ureteral or Renal Location of Urinary Stone	Urinary stone location will be classified as renal or ureter.	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
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm	Size of fragments created will be assessed using the laser fiber size as a comparison.	up to 6 hours

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Holmium Laser; Laser setting; Stone fragmentation
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urinary Calculi; Urolithiasis; Calculi
• Other Study ID Numbers: 2017-0252; A539800 (Other Identifier: UW Madison); SMPH/UROLOGY (Other Identifier: UW Madison); Protocol Version 10/30/2017 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes