TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition

Lisa Laser

Status: Completed

Conditions: Lithotripsy, Laser

Treatments: Other: Laser lithortripsy; Device: Laser lithotripsy with stone recognition

Study type: Interventional

Funder types: Industry

Identifiers

NCT05500534

TELAXMAN

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject scheduled for laser lithotripsy
• Subject aged 18 or older
• Subject able to give consent
• Informed consent documented by signature

Exclusion criteria

• Subject pregnant or nursing

• Subject requiring emergency lithotripsy

• Contraindication for the surgical procedure:

  • Positive urine culture,
  • Unfit for general anesthesia,
  • Therapeutic anticoagulation, or systemic infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

RevoLix HTL+

Experimental group

Description:

Laser lithotripsy using the RevoLix HTL+ with active stone recognition

Treatment:

Device: Laser lithotripsy with stone recognition

Historic control group

Other group

Description:

Laser lithotripsy without active stone recognition

Treatment:

Other: Laser lithortripsy