SP TLF Versus Ho:YAG Laser

NCT05048706 | Completed FDA Device

• 1 other identifier: STUDY00005201
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.

Conditions

Urinary Calculi

Outcome Measures

Primary Outcomes (2)

• To determine the efficiency of SP TFL in dusting stones

  We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec)

  6 months

• Mean ablation energy needed to ablate stone volume

  We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules)

  6 months

Secondary Outcomes (2)

• Number of stones cleared.

  9 months

• Number of participants reporting complications.

  9 months

Study Arms (2)

Super Pulse Thulium fiber Laser

Device: Laser lithotripsy (SP TLF)

Holmium: Yttrium-Aluminium-Garnet Laser

Device: Laser lithotripsy (Ho:YAG)

Interventions

Laser lithotripsy (SP TLF) DEVICE

Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)

Super Pulse Thulium fiber Laser

Laser lithotripsy (Ho:YAG) DEVICE

Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.

Holmium: Yttrium-Aluminium-Garnet Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for this study will be identified via eRecord in the Urology Department (routine access) of patients who were diagnosed with upper urinary tract calculi who underwent surgery utilizing either high powered Ho:YAG or TL-SPL lasers.

You may qualify if:

• Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
• Stones located in the kidney and proximal ureter
• Stones measuring 10-30mm
• Ability to give informed consent
• Any racial or ethnic origin
• Age 18 years and older

You may not qualify if:

• Active kidney infection
• Patients with prior stenting
• Pregnant patients
• Patients with solitary kidney
• Patients with ureteral tumor or stricture
• Inability to give informed consent
• Not age 18 and older

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

Lithotripsy, Laser

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)

Laser Therapy; Therapeutics; Lithotripsy; Ablation Techniques; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Ahmed Ghazi, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: May 10, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)