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Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis (LiThuHol)

U

University Hospital, Angers

Status

Unknown

Conditions

Renal Stone
Ureteral Stone

Treatments

Device: Ureteroscopy for upper tract stone treatment with Holmium laser
Device: Ureteroscopy for upper tract stone treatment with Thulium laser

Study type

Observational

Funder types

Other

Identifiers

NCT04871984
ar21-0020v0

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Holmium laser lithotripsy
Description:
Stone fragmentation are performed with Holmium laser in ureteroscopy
Treatment:
Device: Ureteroscopy for upper tract stone treatment with Holmium laser
Thulium laser lithotripsy
Description:
Stone fragmentation are performed with Thulium laser in ureteroscopy
Treatment:
Device: Ureteroscopy for upper tract stone treatment with Thulium laser

Trial contacts and locations

0

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Central trial contact

Bertrand DELBARRE, Resident; Pierre BIGOT, MD-PhD

Data sourced from clinicaltrials.gov

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