Kidney StoneNCT04346485
Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers
A study testing SP TFL RIRS with 145 mcm fiber, SP TFL RIRS with 200 mcm fiber and Ho:YAG RIRS with 200 mcm fiber in people with Kidney Stone and Nephrolithiasis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows: decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Nephrolithiasis, Urolithiasis
- What is being tested?
- SP TFL RIRS with 145 mcm fiber, SP TFL RIRS with 200 mcm fiber and Ho:YAG RIRS with 200 mcm fiber
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteRussia
- Study dates
- 13 Mar 2020to 31 May 2022
- 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
- Males and Females > 18 y.o.;
- Radiologically confirmed (CT) kidney stone;
- Stone size from 10 to 20 mm.
Who cannot join
- Multiple (more than 3) kidney stones > 5 mm
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, MD, +7 925 517 79 26, enikeev-dv@1msmu.ru
About this study
Official title: Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study
The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:
- decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
- increasing the flexible ureteroscope tip deflection lower pole stones availability;
- decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
- increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter
Read the detailed description
RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.
A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.
- Conditions
- Kidney Stone, Nephrolithiasis, Urolithiasis
- Being tested
- SP TFL RIRS with 145 mcm fiber, SP TFL RIRS with 200 mcm fiber, Ho:YAG RIRS with 200 mcm fiber
- Keywords
- RIRS, holmium laser, superpulse thulium laser, kidney stone disease
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP TFL RIRS with 145 mcm fiberProcedure or surgery
retrograde intrarenal surgery
SP TFL RIRS with 200 mcm fiberProcedure or surgery
retrograde intrarenal surgery
Ho:YAG RIRS with 200 mcm fiberProcedure or surgery
retrograde intrarenal surgery
| Study group | Role | What they receive |
|---|---|---|
| SP TFL RIRS with 145 mcm fiber | Experimental | Superpulse thulium fiber laser RIRS with 145 mcm laser fiber Receives: Procedure: SP TFL RIRS with 145 mcm fiber |
| SP TFL RIRS with 200 mcm fiber | Experimental | Superpulse thulium fiber laser RIRS with 200 mcm laser fiber Receives: Procedure: SP TFL RIRS with 200 mcm fiber |
| Ho:YAG RIRS with 200 mcm fiber | Active comparator | Ho:YAG laser RIRS with 200 mcm laser fiber Receives: Procedure: Ho:YAG RIRS with 200 mcm fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser-on time
Time of laser emission during surgery, seconds
Measured: during surgery
Secondary outcomes (8)
adverse events
Complications according to Clavien-Dindo classification (higher score means more severe complication)
Measured: during surgery and 6 months after surgery
Operative time
Surgery duration, minutes
Measured: during surgery
Hemoglobin drop
Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L
Measured: 1 day after surgery
Catheter stay
duration of catheterisation, days
Measured: 1 week
hospitalization length
Duration of hospital stay after surgery, days
Measured: 1 week
Radiation exposure
Duration of X-ray exposure, sec.
Measured: during surgery
Radiation exposure
Effective dose, mSv
Measured: during surgery
Stone-free rate
Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start13 Mar 2020
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346485
- Sponsor's protocol ID
- Sechenov-RIRS-20
- Status last verified
- Jul 2021
- First submitted
- 12 Mar 2020
- Last updated
- 22 Jul 2021
- 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study
- ClinicalTrials.gov ID
- NCT04346485
- Acronym / sponsor ID
- Sechenov-RIRS-20
- Conditions
- Kidney Stone, Nephrolithiasis, Urolithiasis
- Keywords
- RIRS, holmium laser, superpulse thulium laser, kidney stone disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 15 Apr 2020 (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.
The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:
- decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
- increasing the flexible ureteroscope tip deflection lower pole stones availability;
- decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
- increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter
Detailed description
RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.
A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SP TFL RIRS with 145 mcm fiber | Experimental | Procedure: SP TFL RIRS with 145 mcm fiberSuperpulse thulium fiber laser RIRS with 145 mcm laser fiber |
| SP TFL RIRS with 200 mcm fiber | Experimental | Procedure: SP TFL RIRS with 200 mcm fiberSuperpulse thulium fiber laser RIRS with 200 mcm laser fiber |
| Ho:YAG RIRS with 200 mcm fiber | Active comparator | Procedure: Ho:YAG RIRS with 200 mcm fiberHo:YAG laser RIRS with 200 mcm laser fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females > 18 y.o.;
- Radiologically confirmed (CT) kidney stone;
- Stone size from 10 to 20 mm.
Key exclusion criteria (1 listed)
- Multiple (more than 3) kidney stones > 5 mm
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 |
|---|---|---|
| SP TFL RIRS with 145 mcm fiberretrograde intrarenal surgery | Procedure or surgery | SP TFL RIRS with 145 mcm fiber |
| SP TFL RIRS with 200 mcm fiberretrograde intrarenal surgery | Procedure or surgery | SP TFL RIRS with 200 mcm fiber |
| Ho:YAG RIRS with 200 mcm fiberretrograde intrarenal surgery | Procedure or surgery | Ho:YAG RIRS with 200 mcm fiber |
Primary outcome
Laser-on time
Time frame: during surgery
Time of laser emission during surgery, seconds
8 secondary outcomes
adverse events
Time frame: during surgery and 6 months after surgery
Operative time
Time frame: during surgery
Hemoglobin drop
Time frame: 1 day after surgery
Catheter stay
Time frame: 1 week
hospitalization length
Time frame: 1 week
Radiation exposure
Time frame: during surgery
Radiation exposure
Time frame: during surgery
Stone-free rate
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- 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.
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SP TFL RIRS with 145 mcm fiber, SP TFL RIRS with 200 mcm fiber and Ho:YAG RIRS with 200 mcm fiber in people with Kidney Stone and Nephrolithiasis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser-on time (time frame: during surgery). 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 Jul 2021.