Lithotripsy, LaserNCT05500534
TELAXMAN - Laser Lithotripsy With Automatic Real-time Stone Recognition
A study testing Laser lithotripsy with stone recognition and Laser lithortripsy in people with Lithotripsy, Laser, run by LISA Laser Products GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithotripsy, Laser
- What is being tested?
- Laser lithotripsy with stone recognition and Laser lithortripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 5 Sep 2022to 13 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject scheduled for laser lithotripsy
- Subject aged 18 or older
- Subject able to give consent
- Informed consent documented by signature
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Feasibility Study of a Novel Laser System for Endoscopic Disintegration of Urinary Stones With Automatic Real-time Stone Recognition
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.
Read more
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
- Being tested
- Laser lithotripsy with stone recognition, Laser lithortripsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser lithotripsy with stone recognitionDevice
Application of Revolix HTL+ which features automatic real-time stone recognition
Laser lithortripsyOther
Standard laser lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| RevoLix HTL+ | Experimental | Laser lithotripsy using the RevoLix HTL+ with active stone recognition Receives: Device: Laser lithotripsy with stone recognition |
| Historic control group | Other | Laser lithotripsy without active stone recognition Receives: Other: Laser lithortripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- - Residual fragments ≤4mm
- - 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During the follow up time (up to 3 months)
Secondary outcomes (4)
Total laser emitted energy (J)
Total laser emitted energy is recorded by the laser system during each procedure. This data will be extracted after each procedure for the investigational arm and at the end of the investigation for the matching control arm.
Measured: Immediately (up to 1 hour) after the end of the intervention
Procedure duration (min)
Procedure duration will be recorded in the CRF as the time from endoscope insertion to retraction (Schnitt-Naht Zeit).
Measured: Immediately (up to 1 hour) after the end of the intervention
PULS classification of potential lesions visible via endoscopy immediately after the procedure
Before retracting the ureteroscope, the surgeon will visualize the postoperative ureter along its entire length and record PULS classification in the CRF.
PULS is a 5 grades scale (0 - No lesion; 1 - Superficial mucosal lesion and/or significant mucosal oedema/hematoma; 2 - Submucosal lesion; 3 - Perforation with less than 50% partial transection; 4 - Perforation with more than 50% partial transection; 5 - Complete transection), in which lesions are graded independently of their location and extent. In case of multiple lesions, the most severe grading is applied.
Measured: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
Usability and workflow assessment (surgeon's questionnaire)
Immediately after his/her first procedure with RevoLix HTL+, the surgeon will fill in a questionnaire regarding the different aspects of the laser system.
Measured: Within 12 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start5 Sep 2022
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lithotripsy, LaserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LISA Laser Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Schönthaler, Prof. Dr., Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500534
- Sponsor's protocol ID
- TELAXMAN
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Feasibility Study of a Novel Laser System for Endoscopic Disintegration of Urinary Stones With Automatic Real-time Stone Recognition
- ClinicalTrials.gov ID
- NCT05500534
- Acronym / sponsor ID
- TELAXMAN
- Conditions
- Lithotripsy, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LISA Laser Products GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RevoLix HTL+ | Experimental | Device: Laser lithotripsy with stone recognitionLaser lithotripsy using the RevoLix HTL+ with active stone recognition |
| Historic control group | Other | Other: Laser lithortripsyLaser lithotripsy without active stone recognition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject scheduled for laser lithotripsy
- Subject aged 18 or older
- Subject able to give consent
- Informed consent documented by signature
Key exclusion criteria (6 listed)
- Subject pregnant or nursing
- Subject requiring emergency lithotripsy
- Contraindication for the surgical procedure:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser lithotripsy with stone recognitionApplication of Revolix HTL+ which features automatic real-time stone recognition | Device | RevoLix HTL+ |
| Laser lithortripsyStandard laser lithotripsy | Other | Historic control group |
Primary outcome
Visual assessment of stone-free status;
Time frame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
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.
Visual assessment of stone, tissue and endoscope recognition accuracy during laser lithotripsy
Time frame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
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.
Safety of device - assessment of device deficiencies
Time frame: During laser lithotripsy (duration of max 5 hours)
Safety of the device shall be evaluated by systematically reporting DDs and by monitoring the frequency and incidence of these events
Safety of device - assessment of adverse events during the intervention
Time frame: During laser lithotripsy (duration of max 5 hours)
Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events
Safety of device - assessment of adverse events during the follow up time
Time frame: During the follow up time (up to 3 months)
Safety of the device shall be evaluated by systematically reporting AEs and SAEs and by monitoring the frequency and incidence of these events
New risk identification during the intervention
Time frame: Within 12 hours after the intervention
The practitioner will be asked to identify any new risks arising during laser lithotripsy using the investigational device
New risk identification during the follow up time
Time frame: During the follow up time (up to 3 months)
The practitioner will be asked to identify any new risks related to the investigational device during the follow up time
4 secondary outcomes
Total laser emitted energy (J)
Time frame: Immediately (up to 1 hour) after the end of the intervention
Procedure duration (min)
Time frame: Immediately (up to 1 hour) after the end of the intervention
PULS classification of potential lesions visible via endoscopy immediately after the procedure
Time frame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours
Usability and workflow assessment (surgeon's questionnaire)
Time frame: Within 12 hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schönthaler, Prof. Dr. principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser lithotripsy with stone recognition and Laser lithortripsy in people with Lithotripsy, Laser, run by LISA Laser Products GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assessment of stone-free status; (time frame: During the procedure of laser lithotripsy, which should last for a maximum of 5 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.