Tissue SensorTissue SensorNCT07851116
Tissue Sensor to Reduce the Need for Controlled Apnea During Retrograde Intrarenal Surgery
A study testing RIRS without Tissue Sensor and RIRS with Tissue Sensor in people with Tissue Sensor, run by Botkin Hospital.
Trial summary
Retrograde intrarenal surgery is an established minimally invasive treatment for renal stones. During laser lithotripsy, respiratory motion causes the kidney, renal collecting system, and stone to move relative to the distal tip of the laser fiber. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Sensor
- What is being tested?
- RIRS without Tissue Sensor and RIRS with Tissue Sensor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 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 renal stone.
- An indication for elective RIRS.
- Feasibility of performing the intervention with a flexible ureteroscope.
- Recommended stone diameter on CT: 7-15 mm.
- Stone located in a calyx, a group of calyces, or the renal pelvis.
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- Feasibility of TFL use.
- General anesthesia with controlled mechanical ventilation.
- No active urinary tract infection.
- Ability to undergo low-dose non-contrast CT at 1 month.
- Signed written informed consent.
Who cannot join
- Multiple stones in the study kidney.
- Complete or partial staghorn stone.
- Ipsilateral ureteral stone.
- Renal or upper urinary tract anomaly that substantially alters the anatomy.
- Horseshoe, pelvic, or ectopic kidney.
- Stone within a calyceal diverticulum.
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- Ureteral stricture.
- Previous reconstructive surgery involving the study kidney or ureter.
- Active infection, obstructive pyelonephritis, or urosepsis.
- Nephrostomy drainage.
- Pregnancy.
- Severe respiratory failure or a contraindication to apnea.
- Severe cardiovascular instability.
- Inability to undergo general anesthesia.
- Combined, bilateral, or percutaneous intervention.
- Suspected upper urinary tract tumor.
- Inability to comply with the study protocol.
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
Retrograde intrarenal surgery is an established minimally invasive treatment for renal stones. During laser lithotripsy, respiratory motion causes the kidney, renal collecting system, and stone to move relative to the distal tip of the laser fiber. This can impair precise fiber positioning, reduce operative-field stability, and increase the risk of unintended laser exposure of the urothelium of the renal collecting system.
To reduce respiratory motion of the kidney, the surgeon may ask the anesthesiologist to temporarily pause mechanical ventilation. Controlled apnea can briefly stabilize the operative field; however, it requires interruption of ventilation and may cause oxygen desaturation, carbon dioxide accumulation, hemodynamic changes, and increased anesthetic burden.
Read more
Tissue Sensor is a technology that automatically terminates laser emission when contact between the distal tip of the laser fiber and tissue is detected. Tissue Sensor is expected to reduce the risk of unintended laser exposure of the renal collecting-system mucosa during respiratory motion of the kidney.
Greater surgeon confidence in the safety of laser activation may reduce the need to stabilize the kidney with controlled apnea. At the same time, brief automatic interruptions of laser emission may increase lithotripsy time and total operative time.
- Conditions
- Tissue Sensor
- Being tested
- RIRS without Tissue Sensor, RIRS with Tissue Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRS without Tissue SensorProcedure or surgery
RIRS will be performed using the same TFL system with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the mucosa will be recorded from the procedure video.
RIRS with Tissue SensorProcedure or surgery
RIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording.
- total number of Tissue Sensor trigger events;
- Tissue Sensor trigger events per minute of laser activation.
| Study group | Role | What they receive |
|---|---|---|
| patients with a single renal stone who are scheduled for elective retrograde intrarenal surger | Experimental | RIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording. Receives: Procedure: RIRS without Tissue Sensor; Procedure: RIRS with Tissue Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring at least one episode of controlled intraoperative apnea during laser lithotripsy.
Measured: intraoperative
Secondary outcomes (7)
• number of apnea episodes;
Measured: intraoperative
total apnea duration;
Measured: intraoperative
mean number of apnea episodes per patient;
Measured: intraoperative
maximum duration of a single apnea episode;
Measured: intraoperative
minimum SpO2;
Measured: intraoperative
incidence of desaturation;
Measured: intraoperative
visible laser-induced mucosal
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 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 Tissue SensorStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT07851116
- Sponsor's protocol ID
- MoscowBotkinHospital3
- Acronym
- Tissue Sensor
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sensor to Reduce the Need for Controlled Apnea During Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT07851116
- Acronym / sponsor ID
- Tissue Sensor / MoscowBotkinHospital3
- Conditions
- Tissue Sensor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 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
- 1 Oct 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.
Retrograde intrarenal surgery is an established minimally invasive treatment for renal stones. During laser lithotripsy, respiratory motion causes the kidney, renal collecting system, and stone to move relative to the distal tip of the laser fiber. This can impair precise fiber positioning, reduce operative-field stability, and increase the risk of unintended laser exposure of the urothelium of the renal collecting system.
To reduce respiratory motion of the kidney, the surgeon may ask the anesthesiologist to temporarily pause mechanical ventilation. Controlled apnea can briefly stabilize the operative field; however, it requires interruption of ventilation and may cause oxygen desaturation, carbon dioxide accumulation, hemodynamic changes, and increased anesthetic burden.
Tissue Sensor is a technology that automatically terminates laser emission when contact between the distal tip of the laser fiber and tissue is detected. Tissue Sensor is expected to reduce the risk of unintended laser exposure of the renal collecting-system mucosa during respiratory motion of the kidney.
Greater surgeon confidence in the safety of laser activation may reduce the need to stabilize the kidney with controlled apnea. At the same time, brief automatic interruptions of laser emission may increase lithotripsy time and total operative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a single renal stone who are scheduled for elective retrograde intrarenal surger | Experimental | Procedure: RIRS without Tissue Sensor, Procedure: RIRS with Tissue SensorRIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older.
- A single renal stone.
- An indication for elective RIRS.
- Feasibility of performing the intervention with a flexible ureteroscope.
- Recommended stone diameter on CT: 7-15 mm.
Key exclusion criteria (17 listed)
- Multiple stones in the study kidney.
- Complete or partial staghorn stone.
- Ipsilateral ureteral stone.
- Renal or upper urinary tract anomaly that substantially alters the anatomy.
- Horseshoe, pelvic, or ectopic kidney.
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 |
|---|---|---|
| RIRS without Tissue SensorRIRS will be performed using the same TFL system with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the mucosa will be recorded from the procedure video. | Procedure or surgery | patients with a single renal stone who are scheduled for elective retrograde intrarenal surger |
| RIRS with Tissue SensorRIRS will be performed using a thulium fiber laser with Tissue Sensor activated. All automatic system trigger events will be recorded and, whenever possible, synchronized with the procedure video recording. * total number of Tissue Sensor trigger events; * Tissue Sensor trigger events per minute of laser activation. | Procedure or surgery | patients with a single renal stone who are scheduled for elective retrograde intrarenal surger |
Primary outcome
Proportion of patients requiring at least one episode of controlled intraoperative apnea during laser lithotripsy.
Time frame: intraoperative
7 secondary outcomes
• number of apnea episodes;
Time frame: intraoperative
total apnea duration;
Time frame: intraoperative
mean number of apnea episodes per patient;
Time frame: intraoperative
maximum duration of a single apnea episode;
Time frame: intraoperative
minimum SpO2;
Time frame: intraoperative
incidence of desaturation;
Time frame: intraoperative
visible laser-induced mucosal
Time frame: intraoperative
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 1 Oct 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 RIRS without Tissue Sensor and RIRS with Tissue Sensor in people with Tissue Sensor, 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 11 inclusion and 17 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 1 Oct 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?
Proportion of patients requiring at least one episode of controlled intraoperative apnea during laser lithotripsy. (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 1 Oct 2026.