MOSES Laser System for Kidney Stones
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Albany Medical College
Must not be taking: Anticoagulants
Disqualifiers: Pregnancy, Infection, Cancer, Neurogenic bladder, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on mandatory anticoagulation therapies (blood thinners) and cannot stop them for surgery, you cannot participate.
What data supports the effectiveness of the MOSES laser system treatment for kidney stones?
Is the MOSES Laser System safe for treating kidney stones?
How is the MOSES laser system treatment for kidney stones different from other treatments?
The MOSES laser system is unique because it uses a special pulse technology that reduces stone movement during treatment, making it more efficient at breaking down kidney stones compared to regular laser methods. This can lead to shorter procedure times and potentially lower costs for patients.12458
Eligibility Criteria
This trial is for adults aged 18-80 with large kidney stones (10-20 mm in total diameter) and a stone density of at least 1000 Hounsfield units. Suitable candidates can undergo flexible ureteroscopy. Pregnant individuals, those currently battling infections or cancer, patients with spinal cord injuries, neurogenic bladder, abnormal kidney anatomy, history of certain urinary tract procedures or strictures, prior abdominal/pelvic radiotherapy, or on non-stop anticoagulants are excluded.Inclusion Criteria
The doctor decides if you can have a flexible ureteroscopy.
I have large kidney stones measuring in total 10-20 mm.
Your kidney stone is very dense, with a score of at least 1000 on a special type of X-ray.
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Exclusion Criteria
I have had surgery on the same side as my kidney stones before.
You have had problems with your bladder related to nerve issues in the past.
You have a history of narrowings in the tube that carries urine from one of your kidneys to your bladder.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo flexible ureteroscopy with different lasing techniques (dusting, fragmentation, hybrid) to evaluate total lasing time and energy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the ureteroscopy procedure
4 weeks
Treatment Details
Interventions
- MOSES laser system (Laser Modality)
Trial OverviewThe study tests the MOSES laser system's effectiveness in reducing lasing time and energy during ureteroscopic removal of large dense kidney stones using different techniques: dusting them into fine particles, breaking them into fragments or combining both methods.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Flexible Ureteroscopy with HybridExperimental Treatment1 Intervention
Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.
Group II: Flexible Ureteroscopy with FragmentationExperimental Treatment1 Intervention
Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz
Group III: Flexible Ureteroscopy with DustingExperimental Treatment1 Intervention
Flexible ureteroscopy with the dusting lasing technique. MOSES parameters will be set to an energy of 0.3-0.4 Jules and a frequency of 50-80 hertz
MOSES laser system is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as MOSES laser system for:
- Kidney stones
- Ureteral stones
- Bladder stones
🇪🇺 Approved in European Union as MOSES laser system for:
- Kidney stones
- Ureteral stones
- Bladder stones
🇨🇦 Approved in Canada as MOSES laser system for:
- Kidney stones
- Ureteral stones
- Bladder stones
🇯🇵 Approved in Japan as MOSES laser system for:
- Kidney stones
- Ureteral stones
- Bladder stones
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Albany Medical CollegeAlbany, NY
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Who Is Running the Clinical Trial?
Albany Medical CollegeLead Sponsor
References
Comparison of the efficacy and safety of holmium laser with the Moses technology and regular mode for stone treatment: a systematic review and meta-analysis. [2023]As a new pulse modality of holmium laser in retrograde intrarenal stone surgery, the MOSES technique can reduce the possibility of stone drifting and help to powder kidney stones in vitro and in animal experiments. However, there remains controversy about whether the MOSES mode needs to be used instead of the regular mode in clinical practice. This meta-review was conducted to evaluate the clinical efficacy and safety of MOSES technology for stone disease.
Dusting Efficiency of the Moses Holmium Laser: An Automated In Vitro Assessment. [2019]Moses technology is a novel Holmium:YAG laser system designed to minimize stone retropulsion and improve stone ablation when the laser is not in direct contact with the stone. Our aim was to assess the efficiency of Moses technology relative to short- and long-pulse lithotripsy using an automated in vitro "dusting model" of stone comminution.
Does Moses technology enhance the efficiency and outcomes of regular holmium laser lithotripsy? Results of a pooled analysis of comparative studies. [2023]Holmium laser lithotripsy is currently the optimum standard for surgical treatment of upper urinary calculi. This study aims to evaluate the clinical efficacy and safety of Moses compared with conventional holmium laser lithotripsy for the treatment of patients with upper urinary calculi. We conducted a systematic search using multiple databases (PubMed/Medline, Scopus, Web of Science, and ClinicalTrials.gov) until June 2022. Clinical trials comparing Moses and conventional holmium laser lithotripsy were included. Analysis was performed using RevMan version 5.4.4 software. Four studies with 892 patients were included. There were no significant differences regarding stone-free rate (mean difference [MD] 1.19, 95% CI 0.54, 2.64, p = 0.66), operative time (MD - 9.31, 95% CI - 21.11, 2.48, p = 0.12), fragmentation time (MD - 1.71, 95% CI - 11.81, 8.38, p = 0.74), total energy used (MD 1.23, 95% CI - 0.44, 2.90, p = 0.15), auxiliary procedures (MD 0.38, 95% CI 0.08, 1.90, p = 0.24), and overall complications (odds ratio [OR] 0.70, 95% CI 0.30, 1.66, p = 0.42) between the groups. However, the laser working time (MD - 0.94, 95% CI - 1.20, - 0.67, p
The Moses holmium system - time is money. [2019]The Moses technology of the holmium laser has been shown to decrease retropulsion in the ureter and procedural time in kidney stones during laser lithotripsy. Theoretically, these improvements could lead to cost savings for the patient.
Use of the Moses Technology to Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. [2019]To evaluate in vitro and in vivo effects of Moses technology in Holmium laser and to compare it with the Regular mode in terms of lithotripsy efficiency and laser-tissue interactions.
Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. [2022]Objective: To evaluate the clinical benefits of Moses technology compared with the regular mode with the Lumenis® Pulse™ P120H holmium laser during ureteroscopy for stone disease. Patients and Methods: An IRB-approved database of patients with urolithiasis was analyzed for ureteroscopies from January 2020 to December 2020 at an outpatient surgery center. Patients who underwent ureteroscopy with the Lumenis Pulse P120H holmium laser system with the Moses or regular mode were included. Patient characteristics and stone parameters were collected. Operative room parameters were compared, including procedural time, fragmentation/dusting time, lasing time, and total energy used. Complication rates and stone-free rates were also analyzed. Univariate analysis and multiple analysis of covariance controlling for cumulative stone size were performed. Patients with staged procedures were excluded. Results: Of 197 surgical cases, 176 met the inclusion criteria. Moses was utilized in 110 cases and regular mode in 66. There was no difference in cumulative stone size between Moses and regular modes (11.8 ± 7.9 vs 11.6 ± 9.2 mm, p = 0.901). Procedural time (43.5 ± 32.1 vs 39.8 ± 24.6 minutes, p = 0.436), fragmentation/dusting time (20.5 ± 25.3 vs 17.1 ± 16.1 minutes, p = 0.430), lasing time (7.5 ± 11.1 vs 6.7 ± 7.9 minutes, p = 0.570), and total energy used (5.1 ± 6.7 vs 3.8 ± 4.8 kJ, p = 0.093) were also similar. Complications (6.4% vs 6.1%, p = 0.936) and stone-free rates (52.3% vs 65.3%, p = 0.143) did not differ. Conclusion: At our institution, Moses technology did not significantly change the procedural time, fragmentation/dusting time, lasing time, or total energy used. Moreover, there were no differences in complications or stone-free rates. There may be technical benefits to the Moses technology not captured in this analysis.
Comparison Between Holmium:YAG Laser with MOSES Technology vs Thulium Fiber Laser Lithotripsy in Retrograde Intrarenal Surgery for Kidney Stones in Adults: A Propensity Score-matched Analysis From the FLEXible Ureteroscopy Outcomes Registry. [2023]We evaluated stone-free rate and complications after flexible ureteroscopy for renal stones, comparing thulium fiber laser and holmium:YAG laser with MOSES technology.
Ambulatory Tubeless Mini-Percutaneous Nephrolithotomy Using Moses Technology and Dusting Technique. [2019]To demonstrate the use of the Moses technology for holmium laser lithotripsy in conjunction with mini-percutaneous nephrolithotomy (PCNL) to treat a lower pole stone. The Moses technology is a pulse modulation method that can reduce stone retropulsion, which may have advantages when used during mini-PCNL.