ClinicalTrials.gg
Status unknownNCT04871984LiThuHolUpdated May 4, 2021

Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

An observational study in Renal Stone and Ureteral Stone, sponsored by University Hospital, Angers. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Stone
  • Ureteral Stone
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In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 57 observational studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • non-use of laser for stone lithotripsy
  • pregnant women
  • under 18 years old
  • refusal to give
  • urinary malformation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
14 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

06

What researchers measure

Primary outcomes

  1. Stone free rate

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

    Time frame: Three months after surgery

Secondary outcomes

  1. Perioperative complications

    Recording data about ureteric perforation and bleeding

    Time frame: During the intervention

  2. Operating time

    All surgeries are included

    Time frame: Immediately after the intervention

  3. Postoperative complications

    Recording data according to the Clavien classification (rates of hospitalisation, pain, infection and surgical revision)

    Time frame: Up to three months after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33516610 ↗
  • 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. PubMed 29634144 ↗
  • 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. PubMed 30575354 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2021; primary completion for May 2021, 0 months later.

Of 27 observational studies under Nephrolithiasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 54. This study's planned 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2021
First posted
May 4, 2021
StartEst.
May 2021
Primary completionEst.
May 2021
CompletionEst.
Oct 2022
Last update
May 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04871984
Responsible party
Sponsor
First posted
May 4, 2021
Start date
May 2021 (estimated)
Primary completion
May 2021 (estimated)
Completion
Oct 2022 (estimated)
Last update
May 4, 2021

Study contacts

Pierre BIGOT, MD-PhD
Contact
PiBigot@chu-angers.fr
0241355830 ext. +33
Bertrand DELBARRE, Resident
Contact
Bertrand.Delbarre@chu-angers.fr
0241353518 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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