NephrolithiasisTissue SensorNCT07835113
Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
A study testing Semirigid TFL ureterolithotripsy with Tissue Sensor activated. and Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated. in people with Nephrolithiasis, run by Botkin Hospital.
Trial summary
Tissue Sensor (TS) is a technology designed to automatically deactivate laser emission when contact between the laser fiber and tissue is detected. It is hypothesized that the use of TS during contact laser ureterolithotripsy may reduce unintended laser exposure of the ureteral mucosa, thereby decreasing the risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Semirigid TFL ureterolithotripsy with Tissue Sensor activated. and Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 2 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- • Age 18 years or older.
- A single stone in the mid or distal ureter.
- Maximum stone diameter of 15 mm or less on preoperative CT.
- An indication for elective semirigid laser ureterolithotripsy.
- Feasibility of performing the procedure with a semirigid ureteroscope.
- No active urinary tract infection at the time of the intervention.
- Ability to undergo CT follow-up and complete 12 months of follow-up.
- Signed written informed consent.
Who cannot join
- • Age 18 years or older.
- A single stone in the mid or distal ureter.
- Maximum stone diameter of 15 mm or less on preoperative CT.
- An indication for elective semirigid laser ureterolithotripsy.
- Feasibility of performing the procedure with a semirigid ureteroscope.
- No active urinary tract infection at the time of the intervention.
- Ability to undergo CT follow-up and complete 12 months of follow-up.
- Signed written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tissue Sensor to Reduce Laser-Induced Ureteral Injury During Semirigid Thulium Fiber Laser Ureterolithotripsy: The TISSUE Multicenter Randomized Controlled Trial
Tissue Sensor (TS) is a technology designed to automatically deactivate laser emission when contact between the laser fiber and tissue is detected. It is hypothesized that the use of TS during contact laser ureterolithotripsy may reduce unintended laser exposure of the ureteral mucosa, thereby decreasing the risk of immediate thermal injury to the ureteral wall and subsequent scar-related narrowing.
To reduce the influence of baseline risk factors for stricture, the study will enroll a homogeneous population of patients without urinary tract anomalies, previous surgery on the study ureter, or impacted stones. The procedure will be performed according to a standardized protocol using a semirigid ureteroscope, a thulium fiber laser, and predefined technical restrictions. The study is limited to patients with stones in the mid or distal ureter. This approach is intended to minimize the likelihood of stone retropulsion into the kidney, standardize the surgical technique, reduce the need for conversion to flexible ureteroscopy, and maximize comparability between the study groups.
- Conditions
- Nephrolithiasis
- Being tested
- Semirigid TFL ureterolithotripsy with Tissue Sensor activated., Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semirigid TFL ureterolithotripsy with Tissue Sensor activated.Procedure or surgery
Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording
Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.Procedure or surgery
Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video.
| Study group | Role | What they receive |
|---|---|---|
| Patients after ureterolithotrypsy with Tissue Sensor activated | Experimental | Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording Receives: Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor activated. |
| Patients after ureterolithotrypsy with Tissue Sensor deactivated | Experimental | Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video Receives: Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative laser-induced injury to the ureteral mucosa
Incidence of intraoperative laser-induced injury to the ureteral mucosa, defined as any visible injury compatible with exposure to an activated laser fiber, as determined by independent blinded video assessment.
Measured: intraoperative
Secondary outcomes (1)
Incidence of postoperative ureteral stricture
Incidence of postoperative ureteral stricture detected during the 12 months after the intervention.
- Stone-free rate on low-dose non-contrast CT at 1 month.
- Incidence and total number of Tissue Sensor trigger events in the TS group.
- Incidence and total number of visually confirmed contacts between an activated laser fiber and the mucosa in the control group.
- Number of trigger events or contacts per minute of laser activation.
- Severity of mucosal injury according to the standardized scale.
- Total operative time.
- Lithotripsy time.
- Cumulative laser activation time.
- Migration of the stone or fragments into the kidney.
- Need for conversion to flexible ureteroscopy or repeat intervention.
- Type and duration of postoperative drainage.
- Postoperative complications according to the Clavien-Dindo classification.
- New or progressive hydronephrosis during follow-up.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botkin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malkhasyan Vigen Andreevich, Botkin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835113
- Sponsor's protocol ID
- MoscowBotkinHospital2
- Acronym
- Tissue Sensor
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sensor to Reduce Laser-Induced Ureteral Injury During Semirigid Thulium Fiber Laser Ureterolithotripsy: The TISSUE Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07835113
- Acronym / sponsor ID
- Tissue Sensor / MoscowBotkinHospital2
- Conditions
- Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Botkin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 22 Sep 2026 (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.
Tissue Sensor (TS) is a technology designed to automatically deactivate laser emission when contact between the laser fiber and tissue is detected. It is hypothesized that the use of TS during contact laser ureterolithotripsy may reduce unintended laser exposure of the ureteral mucosa, thereby decreasing the risk of immediate thermal injury to the ureteral wall and subsequent scar-related narrowing.
To reduce the influence of baseline risk factors for stricture, the study will enroll a homogeneous population of patients without urinary tract anomalies, previous surgery on the study ureter, or impacted stones. The procedure will be performed according to a standardized protocol using a semirigid ureteroscope, a thulium fiber laser, and predefined technical restrictions. The study is limited to patients with stones in the mid or distal ureter. This approach is intended to minimize the likelihood of stone retropulsion into the kidney, standardize the surgical technique, reduce the need for conversion to flexible ureteroscopy, and maximize comparability between the study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after ureterolithotrypsy with Tissue Sensor activated | Experimental | Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor activated.Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording |
| Patients after ureterolithotrypsy with Tissue Sensor deactivated | Experimental | Procedure: Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Age 18 years or older.
Key exclusion criteria (8 listed)
- • Age 18 years or older.
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 |
|---|---|---|
| Semirigid TFL ureterolithotripsy with Tissue Sensor activated.Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording | Procedure or surgery | Patients after ureterolithotrypsy with Tissue Sensor activated |
| Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated.Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video. | Procedure or surgery | Patients after ureterolithotrypsy with Tissue Sensor deactivated |
Primary outcome
Incidence of intraoperative laser-induced injury to the ureteral mucosa
Time frame: intraoperative
Incidence of intraoperative laser-induced injury to the ureteral mucosa, defined as any visible injury compatible with exposure to an activated laser fiber, as determined by independent blinded video assessment.
1 secondary outcome
Incidence of postoperative ureteral stricture
Time frame: 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Semirigid TFL ureterolithotripsy with Tissue Sensor activated. and Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated. in people with Nephrolithiasis, run by Botkin Hospital.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikita Astakhov (+8 (968) 490-46-72, astakhov.nikita@inbox.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative laser-induced injury to the ureteral mucosa (time frame: intraoperative). 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 22 Sep 2026.