Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

NCT04871984 | Unknown FDA Device

• 1 other identifier: ar21-0020v0
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published. The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers. The costs and complications will also be studied.

Conditions

Renal Stone; Ureteral Stone

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.

  Three months after surgery

Secondary Outcomes (3)

• Perioperative complications

  During the intervention

• Operating time

  Immediately after the intervention

• Postoperative complications

  Up to three months after surgery

Study Arms (2)

Holmium laser lithotripsy

Stone fragmentation are performed with Holmium laser in ureteroscopy

Device: Ureteroscopy for upper tract stone treatment with Holmium laser

Thulium laser lithotripsy

Stone fragmentation are performed with Thulium laser in ureteroscopy

Device: Ureteroscopy for upper tract stone treatment with Thulium laser

Interventions

Ureteroscopy for upper tract stone treatment with Holmium laser DEVICE

Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser

Holmium laser lithotripsy

Ureteroscopy for upper tract stone treatment with Thulium laser DEVICE

Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser

Thulium laser lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for ureteroscopy on renal or ureteral stones, which have been previously confirmed by tomography

You may qualify if:

• renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
• treatment with rigid or flexible ureteroscopy
• laser lithotripsy during the procedure
• bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)

You may not qualify if:

• non-use of laser for stone lithotripsy
• pregnant women
• under 18 years old
• refusal to give informed consent
• urinary malformation

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (3)

• Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jun-Jul;31(8-9):451-457. doi: 10.1016/j.purol.2020.11.008. Epub 2021 Jan 28.

  PMID: 33516610 BACKGROUND

• Martov AG, Ergakov DV, Guseinov MA, Andronov AS, Dutov SV, Vinnichenko VA, Kovalenko AA. [Initial experience in clinical application of thulium laser contact lithotripsy for transurethral treatment of urolithiasis]. Urologiia. 2018 Mar;(1):112-120. Russian.

  PMID: 29634144 BACKGROUND

• Rapoport LM, Vinarov AZ, Sorokin NI, Dymov AM, Enikeev DV, Tsarichenko DG, Lekarev VY, Klimov RE, Andreeva VA, Kovalenko AA. [Experimental verification of thulium lithotripsy]. Urologiia. 2018 Dec;(5):74-80. Russian.

  PMID: 30575354 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Ureterolithiasis

Interventions

Ureteroscopy; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Pierre BIGOT, MD-PhD

CONTACT

0241355830; PiBigot@chu-angers.fr

Bertrand DELBARRE, Resident

CONTACT

0241353518; Bertrand.Delbarre@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share