Moses vs. Thulium Laser Study

NCT04963062 | Completed Phase 4 Results FDA Device

• 4 other identifiers: 2021-0695A539800SMPH/UROLOGY/UROLOGYProtocol ver 11-29-2021
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities. In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.

Conditions

Urinary Tract Stone

Keywords

Lithotripsy; Holmium laser

Outcome Measures

Primary Outcomes (1)

• Procedural Time (Minutes)

  Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time.

  up to 6 hours

Secondary Outcomes (8)

• Stone Free Rate

  Baseline(pre-operative) and approximately 8 weeks

• Lasing Time (Minutes)

  up to 6 hours

• Total Energy Used (Kilojoules)

  up to 6 hours

• Ablation Efficiency (J/mm^3)

  up to 6 hours

• Number of Participants With Post-operative Complications

  approximately 8 weeks (1 month post-operative)

Study Arms (2)

Participants treated with Holmium laser with the Moses laser

EXPERIMENTAL

Device: Holmium laser with Moses lasers

Participants treated with Holmium laser with the thulium laser

EXPERIMENTAL

Device: Holmium laser with thulium lasers

Interventions

Holmium laser with Moses lasers DEVICE

The holmium laser with Moses is FDA approved. It emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. The goal is to increase stone ablative volume and decrease retropulsion of the stone.

Participants treated with Holmium laser with the Moses laser

Holmium laser with thulium lasers DEVICE

The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns

Participants treated with Holmium laser with the thulium laser

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room
• Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters.

You may not qualify if:

• Participants under 18 years of age and over 89 years old.
• Pregnant participants
• Participants with transplant kidneys
• Participants with irreversible coagulopathy
• Participants with known ureteral stricture disease
• Participants who do not have a pre-operative CT.
• Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Shuang Li
• Organization: University of Wisconsin School of Medicine and Public Health

lis@urology.wisc.edu

608.263.8336

Study Officials

• Stephen Nakada, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: July 16, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 2, 2023
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)