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

• ClinicalTrials.gov Identifier: NCT03526458
• Recruitment Status: Completed
• First Posted: May 16, 2018
• Results First Posted: August 20, 2021
• Last Update Posted: September 20, 2021
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stone Ureter; Stone;Renal; Surgery	Device: Holmium:YAG laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
• Actual Study Start Date: July 30, 2019
• Actual Primary Completion Date: March 24, 2021
• Actual Study Completion Date: March 24, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Fragmentation Time [ Time Frame: up to 6 hours ]
   The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Stephen Nakada, MD; University of Wisconsin, Madison

  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Study Protocol and Statistical Analysis Plan  [PDF] October 30, 2017

Informed Consent Form  [PDF] September 27, 2017

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03526458
• 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 )
• First Posted: May 16, 2018
• Results First Posted: August 20, 2021
• Last Update Posted: September 20, 2021
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by University of Wisconsin, Madison:

Holmium Laser; Laser setting; Stone fragmentation

Additional relevant MeSH terms:

Urinary Calculi; Urolithiasis; Calculi; Pathological Conditions, Anatomical; Urologic Diseases