Kidney StonePhase 3TriHolmiumNCT04559321
Holmium Vs Trilogy Kidney Stones GUY's 1-2
A Phase 3 study testing Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. in people with Kidney Stone and Kidney Calculi, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
Trial summary
The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Kidney Calculi, Kidney Diseases
- What is being tested?
- Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteMexico
- Study dates
- 30 Sep 2020to 1 Sep 2022
- Phase
- Phase 3
- 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
- Male or female patients older than 18 years
- Diagnosis of GUY´s kidney stones 1 and 2 who will undergo a percutaneous mini nephrolithotomy
- Preoperative serum hemoglobin> 10 g / dl
- Preoperative serum creatinine <1.5 mg / dl.
- Surgical risk I-III according to "American Society of Anesthesiologists".
- Previous negative urine culture.
- With postoperative follow-up with computed tomography at three months.
- Patients who are not participating in another project related to the treatment of lithiasis -Who have signed an informed consent where they agree to be part of the study.
Who cannot join
- Patients with a history of coagulopathies.
- Patients with anatomical abnormalities of the urinary tract.
- Pregnant patients.
- Patients with kidney stones GUY´s 3 and 4.
- Patients who do not wish to participate in the clinical trial.
- Patient who due to their physical and / or mental state are not able to sign the informed consent.
- Elimination criteria. Patients who have lost follow-up in the first three months after treatment.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional de Alta Especilidad del bajio
León, Guanajuato, 37660
Edgard Dr Efren, Master, +52 4772672000 ext. 1700, edgardlozada@hotmail.com
Braulio Dr manzo Perez, Dr, +52 4772672000 ext. 1704, braom85@yahoo.com.mx
About this study
Official title: Comparison of the 100 W Holmium Laser Lithotripsy Rate Versus LithoClast Trilogy EMS in Percutaneous Mini-nephrolithotomy for Patients With Kidney Stones GUY's 1 and 2: Randomized Clinical Trial
The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.
The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.
Read more
Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.
As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.
Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.
Read the detailed description
Background The tools used for fragmentation and stone extraction have been improving over time. Commonly available lithotripsy power sources are classified as ultrasonic, kinetic, electrohydraulic, or combination, however, laser is the most widely used lithotripsy device in mini-PCNL as it is a small diameter power source.
Laser lithotripsy The holmium laser has been very effective in the fragmentation of stones of variable hardness and very safe due to its low depth of penetration (0.5 mm).
One of the advantages of the Ho: YAG laser is that it offers relatively quick lithotripsy while minimizing tissue trauma. Furthermore, it is effective against all stone compositions, including cystine and calcium oxalate monohydrate, where ultrasonic lithotripsy may have difficulties.
The removal of smaller fragments is possible using a vacuum effect where the fragments are moved from a high pressure zone in the pyelocaliceal system to a lower pressure zone in the sheath. If there are too many fragments, this requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all of them. This repeated step can cause inadvertent movements that affect the results.
Combined ballistic-ultrasonic lithotripsy LithoClast Trilogy EMS is the newest model of percutaneous lithotripsy technology that provides electromagnetic and ultrasonic ballistic energy, as well as suction capacity under the control of the surgeon through a single pedal. Laboratory studies have suggested that combined ballistic-ultrasonic lithotripsy offers faster stone clearance than other combined and ultrasonic devices. In an in vitro comparison, LithoClast Trilogy EMS had the fastest average removal time of 23.79 seconds. This was followed by ShockPulse (46.04 seconds), Select-US (54.86 seconds), and Select-USP (102.48 seconds).
In a multi-institutional study, LithoClast Trilogy EMS was evaluated, the experience of surgeons with this device was perceived as highly satisfactory, with an excellent safety and durability profile. The average stone removal rate was 68.9 mm2 / minute. High tissue safety and an optimized aspiration configuration were reported in a prospective clinical trial. In this study, the mean stone volume clearance ratios were 370.5 ± 171 mm3 / min and 590.7 ± 250 mm3 / min for mini-PCNL and PCNL, respectively.
LithoClast Trilogy EMS has a single probe design and connects to the handpiece and oscillates with a piezoelectric ultrasonic generator at a rate of 24 kHz. At the same time, an electromagnetic generator produces ballistic motion of the entire probe at an adjustable speed of up to 12 Hz. As with other ultrasound-based devices, suction is available through the hollow probe, with the foot pedal controlling the aspiration and activation of lithotripsy. The strength of the ultrasonic vibration, the aspiration and the ballistic energy discharge frequency are adjustable through a touch screen on the generator. Various probe sizes are available (3.3 F, 4.5 F, 5.7 F, 10.2 F, and 11.7 F catheter).
JUSTIFICATION The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.
The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.
Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.
As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.
Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.
PROBLEM STATEMENT What is the difference of the lithotripsy rate with LithoClast Trilogy EMS compared to 100 W Holmium laser for patients with kidney stones GUY's 1 and 2 in percutaneous mini nephrolithotomy?
HYPOTHESIS H0: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a higher lithotripsy rate than that performed with a 100W Holmium laser.
Hi: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a lower lithotripsy rate than that performed with a 100W Holmium laser.
- Conditions
- Kidney Stone, Kidney Calculi, Kidney Diseases
- Being tested
- Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.
- Keywords
- Kidney Calculi
- Medical subject headings
- Kidney Calculi, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.Procedure or surgery
Also called Trilogy Vs Laser Holmium
General anesthesia, Valdivia-Galdakao position, cystoscopy and ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization
| Study group | Role | What they receive |
|---|---|---|
| Holmium laser | Active comparator | General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser. Receives: Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. |
| Trilogy | Experimental | General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with LithoClast Trilogy EMS and 1.5 mm x 440 mm probe Receives: Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Stone clearance
defined as the kidney stone surface area in square millimeters measured by pre-operative computed tomography scan divided by the time to remove the targeted stone burden in minutes
Measured: 10 minutes
Secondary outcomes (1)
Complications during surgery
All complications measured by the Clavien Classification of Surgical Complications during surgery.
Measured: 3 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 2020
- Study start30 Sep 2020 (estimated)
- Primary completion2 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 116 cases will be subjected to a simple randomization with a table of random numbers, 58 patients will undergo a percutaneous mini nephrolithotomy and lithotripsy with LithoClast Trilogy EMS; and the remaining 58 will undergo 100W Holmium laser lithotripsy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Collaborators
- Braulio Omar Manzo Pérez, Edson Dazaeb Flores Hernández, Pompeyo Stalin Alarcón Vigil
- Responsible party
- Principal investigator, Edgard Lozada, Hospital Regional de Alta Especialidad del Bajio
- Investigators
- Edgard Efren Dr Lozada Hernandez, Master, Study director, Hospital Regional de Alta Especialidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559321
- Sponsor's protocol ID
- CI-HRAEB-056-2020
- Acronym
- TriHolmium
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via email, any researcher may request the database.
Publications
Scotland KB, Kroczak T, Pace KT, Chew BH. Stone technology: intracorporeal lithotripters. World J Urol. 2017 Sep;35(9):1347-1351. doi: 10.1007/s00345-017-2057-x. Epub 2017 Jun 12.
PubMed 28608192Vassar GJ, Chan KF, Teichman JM, Glickman RD, Weintraub ST, Pfefer TJ, Welch AJ. Holmium: YAG lithotripsy: photothermal mechanism. J Endourol. 1999 Apr;13(3):181-90. doi: 10.1089/end.1999.13.181.
PubMed 10360498Okhunov Z, del Junco M, Yoon R, Labadie K, Lusch A, Ordon M. In vitro evaluation of LithAssist: a novel combined holmium laser and suction device. J Endourol. 2014 Aug;28(8):980-4. doi: 10.1089/end.2014.0111. Epub 2014 May 8.
PubMed 24707884Dauw CA, Borofsky MS, York N, Lingeman JE. A Usability Comparison of Laser Suction Handpieces for Percutaneous Nephrolithotomy. J Endourol. 2016 Nov;30(11):1165-1168. doi: 10.1089/end.2016.0203.
PubMed 27758119Carlos EC, Wollin DA, Winship BB, Jiang R, Radvak D, Chew BH, Gustafson MR, Simmons WN, Zhong P, Preminger GM, Lipkin ME. In Vitro Comparison of a Novel Single Probe Dual-Energy Lithotripter to Current Devices. J Endourol. 2018 Jun;32(6):534-540. doi: 10.1089/end.2018.0143. Epub 2018 May 11.
PubMed 29649900Nottingham CU, Large T, Cobb K, Sur RL, Canvasser NE, Stoughton CL, Krambeck AE. Initial Clinical Experience with Swiss LithoClast Trilogy During Percutaneous Nephrolithotomy. J Endourol. 2020 Feb;34(2):151-155. doi: 10.1089/end.2019.0561. Epub 2019 Nov 12.
PubMed 31588790Sabnis RB, Balaji SS, Sonawane PL, Sharma R, Vijayakumar M, Singh AG, Ganpule AP, Desai MR. EMS Lithoclast Trilogy: an effective single-probe dual-energy lithotripter for mini and standard PCNL. World J Urol. 2020 Apr;38(4):1043-1050. doi: 10.1007/s00345-019-02843-2. Epub 2019 Jun 8.
PubMed 31177306Wollin DA, Lipkin ME. Emerging Technologies in Ultrasonic and Pneumatic Lithotripsy. Urol Clin North Am. 2019 May;46(2):207-213. doi: 10.1016/j.ucl.2018.12.006.
PubMed 30961854Manzo BO, Lozada Hernandez EE, Casale AR, Jimenez CJ, Gomez YR, Galvan JP, Alarcon P, Flores E, Mendez DM, Sanchez HM. Trilogy vs 100 W Ho: YAG Laser for Lithotripsy in Mini-Percutaneous Nephrolithotomy: Superior Stone-Free Rates in a Randomized Controlled Trial. Urology. 2025 Aug;202:18-24. doi: 10.1016/j.urology.2025.04.005. Epub 2025 Apr 8.
PubMed 40210001
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 100 W Holmium Laser Lithotripsy Rate Versus LithoClast Trilogy EMS in Percutaneous Mini-nephrolithotomy for Patients With Kidney Stones GUY's 1 and 2: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04559321
- Acronym / sponsor ID
- TriHolmium / CI-HRAEB-056-2020
- Conditions
- Kidney Stone, Kidney Calculi, Kidney Diseases
- Keywords
- Kidney Calculi
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Collaborators
- Braulio Omar Manzo Pérez, Edson Dazaeb Flores Hernández, Pompeyo Stalin Alarcón Vigil
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 2 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 Sep 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 desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.
The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.
Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.
As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.
Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.
Detailed description
Background The tools used for fragmentation and stone extraction have been improving over time. Commonly available lithotripsy power sources are classified as ultrasonic, kinetic, electrohydraulic, or combination, however, laser is the most widely used lithotripsy device in mini-PCNL as it is a small diameter power source.
Laser lithotripsy The holmium laser has been very effective in the fragmentation of stones of variable hardness and very safe due to its low depth of penetration (0.5 mm).
One of the advantages of the Ho: YAG laser is that it offers relatively quick lithotripsy while minimizing tissue trauma. Furthermore, it is effective against all stone compositions, including cystine and calcium oxalate monohydrate, where ultrasonic lithotripsy may have difficulties.
The removal of smaller fragments is possible using a vacuum effect where the fragments are moved from a high pressure zone in the pyelocaliceal system to a lower pressure zone in the sheath. If there are too many fragments, this requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all of them. This repeated step can cause inadvertent movements that affect the results.
Combined ballistic-ultrasonic lithotripsy LithoClast Trilogy EMS is the newest model of percutaneous lithotripsy technology that provides electromagnetic and ultrasonic ballistic energy, as well as suction capacity under the control of the surgeon through a single pedal. Laboratory studies have suggested that combined ballistic-ultrasonic lithotripsy offers faster stone clearance than other combined and ultrasonic devices. In an in vitro comparison, LithoClast Trilogy EMS had the fastest average removal time of 23.79 seconds. This was followed by ShockPulse (46.04 seconds), Select-US (54.86 seconds), and Select-USP (102.48 seconds).
In a multi-institutional study, LithoClast Trilogy EMS was evaluated, the experience of surgeons with this device was perceived as highly satisfactory, with an excellent safety and durability profile. The average stone removal rate was 68.9 mm2 / minute. High tissue safety and an optimized aspiration configuration were reported in a prospective clinical trial. In this study, the mean stone volume clearance ratios were 370.5 ± 171 mm3 / min and 590.7 ± 250 mm3 / min for mini-PCNL and PCNL, respectively.
LithoClast Trilogy EMS has a single probe design and connects to the handpiece and oscillates with a piezoelectric ultrasonic generator at a rate of 24 kHz. At the same time, an electromagnetic generator produces ballistic motion of the entire probe at an adjustable speed of up to 12 Hz. As with other ultrasound-based devices, suction is available through the hollow probe, with the foot pedal controlling the aspiration and activation of lithotripsy. The strength of the ultrasonic vibration, the aspiration and the ballistic energy discharge frequency are adjustable through a touch screen on the generator. Various probe sizes are available (3.3 F, 4.5 F, 5.7 F, 10.2 F, and 11.7 F catheter).
JUSTIFICATION The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.
The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.
Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.
As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.
Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.
PROBLEM STATEMENT What is the difference of the lithotripsy rate with LithoClast Trilogy EMS compared to 100 W Holmium laser for patients with kidney stones GUY's 1 and 2 in percutaneous mini nephrolithotomy?
HYPOTHESIS H0: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a higher lithotripsy rate than that performed with a 100W Holmium laser.
Hi: Lithotripsy performed with LithoClast Trilogy EMS in patients with GUY's 1 and 2 kidney stones undergoing percutaneous mini nephrolithotomy has a lower lithotripsy rate than that performed with a 100W Holmium laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 116 cases will be subjected to a simple randomization with a table of random numbers, 58 patients will undergo a percutaneous mini nephrolithotomy and lithotripsy with LithoClast Trilogy EMS; and the remaining 58 will undergo 100W Holmium laser lithotripsy.
| Arm | Type | Receives |
|---|---|---|
| Holmium laser | Active comparator | Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser. |
| Trilogy | Experimental | Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with LithoClast Trilogy EMS and 1.5 mm x 440 mm probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients older than 18 years
- Diagnosis of GUY´s kidney stones 1 and 2 who will undergo a percutaneous mini nephrolithotomy
- Preoperative serum hemoglobin> 10 g / dl
- Preoperative serum creatinine <1.5 mg / dl.
- Surgical risk I-III according to "American Society of Anesthesiologists".
Key exclusion criteria (7 listed)
- Patients with a history of coagulopathies.
- Patients with anatomical abnormalities of the urinary tract.
- Pregnant patients.
- Patients with kidney stones GUY´s 3 and 4.
- Patients who do not wish to participate in the clinical trial.
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 |
|---|---|---|
| Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.Also: Trilogy Vs Laser HolmiumGeneral anesthesia, Valdivia-Galdakao position, cystoscopy and ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization | Procedure or surgery | Holmium laser, Trilogy |
Primary outcome
Rate of Stone clearance
Time frame: 10 minutes
defined as the kidney stone surface area in square millimeters measured by pre-operative computed tomography scan divided by the time to remove the targeted stone burden in minutes
1 secondary outcome
Complications during surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Results publication: PubMed 28608192Scotland KB, Kroczak T, Pace KT, Chew BH. Stone technology: intracorporeal lithotripters. World J Urol. 2017 Sep;35(9):1347-1351. doi: 10.1007/s00345-017-2057-x. Epub 2017 Jun 12.
- Results publication: PubMed 10360498Vassar GJ, Chan KF, Teichman JM, Glickman RD, Weintraub ST, Pfefer TJ, Welch AJ. Holmium: YAG lithotripsy: photothermal mechanism. J Endourol. 1999 Apr;13(3):181-90. doi: 10.1089/end.1999.13.181.
- Results publication: PubMed 24707884Okhunov Z, del Junco M, Yoon R, Labadie K, Lusch A, Ordon M. In vitro evaluation of LithAssist: a novel combined holmium laser and suction device. J Endourol. 2014 Aug;28(8):980-4. doi: 10.1089/end.2014.0111. Epub 2014 May 8.
- Results publication: PubMed 27758119Dauw CA, Borofsky MS, York N, Lingeman JE. A Usability Comparison of Laser Suction Handpieces for Percutaneous Nephrolithotomy. J Endourol. 2016 Nov;30(11):1165-1168. doi: 10.1089/end.2016.0203.
- Results publication: PubMed 29649900Carlos EC, Wollin DA, Winship BB, Jiang R, Radvak D, Chew BH, Gustafson MR, Simmons WN, Zhong P, Preminger GM, Lipkin ME. In Vitro Comparison of a Novel Single Probe Dual-Energy Lithotripter to Current Devices. J Endourol. 2018 Jun;32(6):534-540. doi: 10.1089/end.2018.0143. Epub 2018 May 11.
- Results publication: PubMed 31588790Nottingham CU, Large T, Cobb K, Sur RL, Canvasser NE, Stoughton CL, Krambeck AE. Initial Clinical Experience with Swiss LithoClast Trilogy During Percutaneous Nephrolithotomy. J Endourol. 2020 Feb;34(2):151-155. doi: 10.1089/end.2019.0561. Epub 2019 Nov 12.
- Results publication: PubMed 31177306Sabnis RB, Balaji SS, Sonawane PL, Sharma R, Vijayakumar M, Singh AG, Ganpule AP, Desai MR. EMS Lithoclast Trilogy: an effective single-probe dual-energy lithotripter for mini and standard PCNL. World J Urol. 2020 Apr;38(4):1043-1050. doi: 10.1007/s00345-019-02843-2. Epub 2019 Jun 8.
- Results publication: PubMed 30961854Wollin DA, Lipkin ME. Emerging Technologies in Ultrasonic and Pneumatic Lithotripsy. Urol Clin North Am. 2019 May;46(2):207-213. doi: 10.1016/j.ucl.2018.12.006.
- Derived from this study: PubMed 40210001Manzo BO, Lozada Hernandez EE, Casale AR, Jimenez CJ, Gomez YR, Galvan JP, Alarcon P, Flores E, Mendez DM, Sanchez HM. Trilogy vs 100 W Ho: YAG Laser for Lithotripsy in Mini-Percutaneous Nephrolithotomy: Superior Stone-Free Rates in a Randomized Controlled Trial. Urology. 2025 Aug;202:18-24. doi: 10.1016/j.urology.2025.04.005. Epub 2025 Apr 8.
- Individual participant dataSharing planned: Yes. Via email, any researcher may request the database.
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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.
Edgard Efren Dr Lozada Hernandez, Master study director
Hospital Regional de Alta Especialidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. in people with Kidney Stone and Kidney Calculi, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
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 7 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 Sep 2020. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Edgard Efren Dr Lozada Hernandez, Master (+524772672000 ext. 1700, edgardlozada@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Stone clearance (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559321, which also lists 9 linked publications.
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 2020.