Holmium Vs Trilogy Kidney Stones GUY's 1-2
NCT04559321 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2020-09-22
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.
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.
Conditions
- Kidney Stone
- Kidney Calculi
- Kidney Diseases
Interventions
- 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 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
Sponsors & Collaborators
-
Braulio Omar Manzo Pérez
collaborator UNKNOWN -
Edson Dazaeb Flores Hernández
collaborator UNKNOWN -
Pompeyo Stalin Alarcón Vigil
collaborator UNKNOWN -
Hospital Regional de Alta Especialidad del Bajio
lead OTHER
Principal Investigators
-
Edgard Efren Dr Lozada Hernandez, Master · Hospital Regional de Alta Especialidad
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-30
- Primary Completion
- 2021-09-02
- Completion
- 2022-09-01
Countries
- Mexico
Study Locations
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