Health TrialsbyHealthPanel

Tissue Sensor to Reduce the Need for Controlled Apnea During Retrograde Intrarenal Surgery

ConditionTissue Sensor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBotkin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

A single renal stone.

An indication for elective RIRS.

Feasibility of performing the intervention with a flexible ureteroscope.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • RIRS without Tissue Sensor

    Procedure/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 Sensor

    Procedure/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.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: patients with a single renal stone who are scheduled for elective retrograde intrarenal surgerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients requiring at least one episode of controlled intraoperative apnea during laser lithotripsy.

Time frame
intraoperative

Secondary outcomes

1

• number of apnea episodes;

Time frame
intraoperative
2

total apnea duration;

Time frame
intraoperative
3

mean number of apnea episodes per patient;

Time frame
intraoperative
4

maximum duration of a single apnea episode;

Time frame
intraoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Botkin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: