TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition

NCT05500534 | Completed

• 1 other identifier: TELAXMAN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lithotripsy, Laser

Outcome Measures

Primary Outcomes (7)

• Visual assessment of stone-free status;

  Before retracting the ureteroscope, the surgeon will visualize the postoperative ureter along its entire length and record the stone-free status in the CRF, using the following scale: 0 - No residue 1. \- Residual fragments ≤4mm 2. \- Residual fragments \>4mm Stone-free status is the state-of-the-art methodology for the description of the lithotripsy procedure, which is performed routinely at the investigation site. It does not require any additional invasive testing or procedures and it is performed intra-operatively.

  During the procedure of laser lithotripsy, which should last for a maximum of 5 hours

• Visual assessment of stone, tissue and endoscope recognition accuracy during laser lithotripsy

  During the procedure, the surgeon will record every incidence of misrecognition by the RevoLix HTL+. Misrecognition is defined as inadequate laser pulse release on healthy tissue or endoscope.

  During the procedure of laser lithotripsy, which should last for a maximum of 5 hours

• Safety of device - assessment of device deficiencies

  Safety of the device shall be evaluated by systematically reporting DDs and by monitoring the frequency and incidence of these events

  During laser lithotripsy (duration of max 5 hours)

• Safety of device - assessment of adverse events during the intervention

  Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events

  During laser lithotripsy (duration of max 5 hours)

• Safety of device - assessment of adverse events during the follow up time

  Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events

  During the follow up time (up to 3 months)

• New risk identification during the intervention

  The practitioner will be asked to identify any new risks arising during laser lithotripsy using the investigational device

  Within 12 hours after the intervention

• New risk identification during the follow up time

  The practitioner will be asked to identify any new risks related to the investigational device during the follow up time

  During the follow up time (up to 3 months)

Secondary Outcomes (4)

• Total laser emitted energy (J)

  Immediately (up to 1 hour) after the end of the intervention

• Procedure duration (min)

  Immediately (up to 1 hour) after the end of the intervention

• PULS classification of potential lesions visible via endoscopy immediately after the procedure

  During the procedure of laser lithotripsy, which should last for a maximum of 5 hours

• Usability and workflow assessment (surgeon's questionnaire)

  Within 12 hours after the intervention

Study Arms (2)

RevoLix HTL+

EXPERIMENTAL

Laser lithotripsy using the RevoLix HTL+ with active stone recognition

Device: Laser lithotripsy with stone recognition

Historic control group

OTHER

Laser lithotripsy without active stone recognition

Other: Laser lithortripsy

Interventions

Laser lithotripsy with stone recognition DEVICE

Application of Revolix HTL+ which features automatic real-time stone recognition

RevoLix HTL+

Laser lithortripsy OTHER

Standard laser lithotripsy

Historic control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• LISA Laser Products GmbH: lead

Study Sites (1)

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Interventions

Lithotripsy, Laser

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Lithotripsy; Ablation Techniques; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Martin Schönthaler, Prof. Dr.

  Universitätsklinikum Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants will be scheduled for laser lithotripsy using the investigational device. A comparator arm will also be included, being composed of retrospective, anonymised and non-study related data of patients who underwent laser lithotripsy with a device used in routine lithotripsy interventions at the investigational site.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: September 5, 2022
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)