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Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04871984
Acronym
LiThuHol
Enrollment
200
Registered
2021-05-04
Start date
2021-05-31
Completion date
2022-10-31
Last updated
2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone, Ureteral Stone

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.

Interventions

DEVICEUreteroscopy for upper tract stone treatment with Holmium laser

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

DEVICEUreteroscopy for upper tract stone treatment with Thulium laser

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Stone free rateThree months after surgeryUrinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.

Secondary

MeasureTime frameDescription
Perioperative complicationsDuring the interventionRecording data about ureteric perforation and bleeding
Operating timeImmediately after the interventionAll surgeries are included
Postoperative complicationsUp to three months after surgeryRecording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision)

Contacts

Primary ContactPierre BIGOT, MD-PhD
PiBigot@chu-angers.fr0241355830
Backup ContactBertrand DELBARRE, Resident
Bertrand.Delbarre@chu-angers.fr0241353518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026