NCT05500534

TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition

Completed NA Last updated 21 August 2024

What this trial tests

NA trial testing Laser lithotripsy with stone recognition in Lithotripsy, Laser in 40 participants. Completed in 13 August 2024.

Timeline

5 September 2022

Primary endpoint
13 August 2024

13 August 2024

Quick facts

Lead sponsor	LISA Laser Products GmbH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	5 September 2022
Primary completion	13 August 2024
Estimated completion	13 August 2024
Sites	1 location across Germany

Drugs / interventions tested

• Laser lithotripsy with stone recognition
• Laser lithortripsy

Conditions studied

• Lithotripsy, Laser — all drugs for Lithotripsy, Laser →

Sponsor

LISA Laser Products GmbH

Who can join

18 and older, any sex, with Lithotripsy, Laser. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Urolithiasis is an extremely common disease affecting about 12% of the world population with increasing tendency. Urinary stones are sediments that form in the kidney from crystals, such as calcium oxalate.

Currently, urological endoscopy with laser lithotripsy represents the leading and most frequently used method for the treatment of urinary stones of different localization, size and composition.

Surgical urology, including interventional stone treatment, is highly influenced by technology. With regard to fragmentation properties and effectiveness for all stone types Holmium:yttrium-aluminium-garnet (Ho:YAG) laser lithotripsy has become the standard technology to disintegrate urinary calculi.

In addition, other kinds of lasers are emerging, such as the thulium fiber laser (TFL); a new solid-state, diode-pumped laser that may provide urologists with increased options for stone treatment.

While urolithiasis treatment in general and laser lithotripsy in specific rarely goes along with major complications, recent studies have shown that there are possible indirect risks to the treatment with lasers, such as thermal damages to the urinary tract even at low-power settings if inadequate irrigation is applied. Sufficient irrigation is mandatory to perform safe Ho:YAG laser lithotripsy.

The RevoLix HTL+ automatic real-time stone detection module was developed to overcome these limitations and improve the safety of the patient with regard to potential thermal damages.

The objective of this clinical investigation is to assess the feasibility of stone recognition and disintegration with the RevoLix HTL+ in clinical conditions and to identify hypotheses to be used in future clinical investigations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.