SP TLF Versus Ho:YAG Laser

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05048706
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 19.7
• Patients Per Site: 50
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

We 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. We hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters [1]. 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Calculi	Device: Laser lithotripsy (SP TLF); Device: Laser lithotripsy (Ho:YAG)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
• Actual Study Start Date: May 10, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Super Pulse Thulium fiber Laser	Device: Laser lithotripsy (SP TLF); Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
Active Comparator: Holmium: Yttrium-Aluminium-Garnet Laser	Device: Laser lithotripsy (Ho:YAG); Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.

Outcome Measures

Primary Outcome Measures

1. To determine the efficiency of SP TFL in dusting stones [6 months]

   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)

2. Mean ablation energy needed to ablate stone volume [6 months]

   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)

Secondary Outcome Measures

1. Number of stones cleared. [9 months]

   We plan to assess the direct impact of SP TFL to produce finer quality dust following disregarding of 10-30mm stones in the upper urinary tract that can spontaneously pass without the need for stenting . Metrics will be stone clearance on postoperative CT scans

2. Number of participants reporting complications. [9 months]

   We plan to assess the direct impact of SP TFL to safely dust 10-30mm stones in the upper urinary tract . Metrics collected will include review of medical record for the presence of complications (e.g. infection, sepsis, obstruction etc.) for 3 months postoperative related to laser lithotripsy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642
2	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Ahmed Ghazi, MD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Ghazi, Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT05048706
• Other Study ID Numbers: STUDY00003725
• First Posted: Sep 17, 2021
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Calculi; Urolithiasis; Calculi

Study Results

No Results Posted as of Sep 17, 2021