TFL vs MOSES Laser for Kidney Stones
Recruiting in Palo Alto (17 mi)
Overseen byHazem Elmansy, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thunder Bay Regional Health Research Institute
Must not be taking: Anticoagulants
Disqualifiers: Ureteral stones, Pregnancy, Solitary kidney, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study aims to compare the efficacy and safety of both types of lasers, Holmium MOSES and TFL, in management of kidney stones requiring treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants or blood thinners, they must be withheld before surgery.
What data supports the idea that TFL vs MOSES Laser for Kidney Stones is an effective treatment?
The available research shows that both the Thulium Fiber Laser (TFL) and the MOSES Holmium Laser are effective treatments for kidney stones. In one study, both lasers had similar success rates in making patients stone-free shortly after the procedure and one month later. Another study found that both lasers were equally effective in breaking down kidney stones during a procedure called flexible ureteroscopy. While the MOSES laser was faster for certain types of stones, overall, both treatments were comparable in terms of effectiveness and safety. This suggests that both TFL and MOSES lasers are good options for treating kidney stones.
12345What safety data is available for TFL and MOSES laser treatments for kidney stones?
The safety data for TFL and MOSES laser treatments for kidney stones indicate that both technologies have comparable efficacy and safety profiles. Studies show no significant differences in complication rates or stone-free rates between the two laser systems. The MOSES technology, when compared to regular holmium laser modes, does not significantly alter procedural times or increase complications. Both TFL and MOSES are effective for lithotripsy, with similar outcomes in terms of stone fragmentation and dusting efficiency. Overall, both laser systems are considered safe for use in kidney stone management.
24567Is the MOSES Holmium Laser, Thulium Fibre Laser treatment promising for kidney stones?
Yes, the MOSES Holmium Laser and Thulium Fibre Laser are promising treatments for kidney stones. They both show similar effectiveness in breaking down stones and achieving stone-free results. The Thulium Fibre Laser is noted for its efficiency and shorter operation time, while the MOSES Laser is effective, especially with certain types of stones. Both treatments are comparable in terms of energy use and safety.
45789Eligibility Criteria
This trial is for adults over 18 with kidney stones sized 10-20 mm or multiple stones in one calyx. They must understand and consent to the study, be able to follow its procedures, and not have had previous shock wave treatments for the same stone. Pregnant individuals, those with certain preexisting conditions, a solitary kidney, additional ureteral stones or strictures, very large or numerous differently located stones, untreated urinary infections or uncorrected bleeding disorders are excluded.Inclusion Criteria
I have kidney stones that are 10-20 mm large or multiple stones in one area.
Ability to comply with the requirements of the study procedures
Written informed consent to participate in the study
+1 more
Exclusion Criteria
I have a stone or narrowing in the tube on the same side as my bladder.
You have kidney stones that are larger than 20 mm or have multiple stones in different parts of your kidney.
I do not have an active urinary tract infection, or it is being treated.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo treatment using either the MOSES Holmium laser or the Thulium Fiber Laser (TFL) for kidney stone management
Intraoperative
1 visit (in-person)
Follow-up
Participants are monitored for stone-free rate and post-op complications
12 weeks
2 visits (in-person)
Participant Groups
The study compares two laser technologies: Thulium Fiber Laser (TFL) and MOSES Holmium Laser in treating kidney stones. It aims to determine which laser is more effective and safe for patients requiring removal of these stones through ureteroscopy.
2Treatment groups
Experimental Treatment
Group I: Thulium Fibre Laser (TFL)Experimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the TFL.
Group II: MOSES Holmium LaserExperimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
MOSES Holmium Laser is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Holmium Laser for:
- Kidney stones
- Benign prostatic hyperplasia (BPH)
- Urinary tract stones
🇪🇺 Approved in European Union as Holmium Laser for:
- Kidney stones
- Benign prostatic hyperplasia (BPH)
- Urinary tract stones
🇨🇦 Approved in Canada as Holmium Laser for:
- Kidney stones
- Benign prostatic hyperplasia (BPH)
- Urinary tract stones
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Thunder Bay Regional Health Sciences CentreThunder Bay, Canada
Loading ...
Who Is Running the Clinical Trial?
Thunder Bay Regional Health Research InstituteLead Sponsor
Thunder Bay Regional Research InstituteLead Sponsor
References
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.
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.
Initial Clinical Experience with a Modulated Holmium Laser Pulse-Moses Technology: Does It Enhance Laser Lithotripsy Efficacy? [2020]Label="OBJECTIVE">The Lumenis® High-power Holmium Laser (120H) has a unique modulated pulse mode, Moses™ technology. Moses technology modulates the laser pulse to separate the water (vapor bubble), then deliver the remaining energy through the bubble. Proprietary laser fibers were designed for the Moses technology. Our aim was to compare stone lithotripsy with and without the Moses technology.
High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. [2022]Purpose: To present initial clinical comparison between high-power holmium laser with MOSES technology (HPH-M) and thulium fiber laser (TFL) during mini-percutaneous nephrolithotomy (PCNL) for renal calculi with specific emphasis on fragmentation efficiency, fragment size distribution, and stone-free rates (SFRs). Materials and Methods: Between August 2018 and December 2019, we performed mini-PCNL for renal calculi <3 cm using HPH-M (Lumenis, Israel) or TFL (Urolase SP, IPG Photonics). Data were collected prospectively in our institutional stone registry. Propensity score matching (1:1) was performed using stone size and density as predictors resulting in matched cohort of 51 patients in each group. Mini-PCNL with active suction sheath was standard across all patients. Primary end-point was SFR at immediate postprocedure and 1 month using CT/kidney, ureter, and bladder radiograph. Stone fragments were retrieved and segregated to assess proportion of dust (<1 mm), small (1-3 mm), and large (>3 mm) fragments. Result: Both groups were comparable in terms of stone size (p = 0.74), volume (p = 0.17), and density (p = 0.69). SFR at 48 hours was 78.43% in HPH-M group and 68.63% in TFL group. Patients with residual fragments were completely clear at 1 month. Lasing time (678.6 vs 551.95 seconds; p = 0.17), stone fragmentation rate (4.6 vs 5.2 mm3/s; p = 0.23), and total laser energy (21.9 vs 16.3 KJ; p = 0.09) were comparable in both arms. Both groups produced similar dusting (46.8 vs 46.41%; p = 0.93). TFL produced a greater proportion of fragments >3 mm (36% vs 22.68%, p = 0.002). On subset analysis based on stone density, all outcome parameters were comparable except a shorter total operative time with TFL (p ≤ 0.05). Conclusion: HPH-M and TFL showed similar SFR. Within constraints of the laser fiber size and energy settings, both modalities were equivalent in terms of fragmentation efficiency and proportion of dusting across stone densities.
Thulium Fiber Laser vs Pulse-Modulated Holmium MOSES Laser in Flexible Ureteroscopy for the Management of Kidney Stones: A Single-Center Retrospective Analysis. [2023]Introduction and Objective: The study's primary objective was to compare the laser efficiency and clinical outcomes of two widely used systems, the holmium MOSES laser and the thulium fiber laser (TFL), in managing kidney stones. The secondary outcomes were to evaluate the impact of stone composition on laser efficacy. Methods: We conducted a retrospective review of patients who underwent flexible ureteroscopy (f-URS) for solitary renal calculi between December 2020 and August 2022 at our institution and had a 3-month postoperative CT scan. Patient demographics and stone parameters were recorded, including stone site, size, volume, and density. Intraoperative data were collected and analyzed, including total operative time, ureteroscopy time, lasing time, technique, total energy delivered, and stone composition. All patients underwent a CT scan at 3 months follow-up. We recorded the presence of residual stones and the percentage of stone volume reduction. Ablation efficiency was calculated by dividing the energy utilized (J) by the stone volume (mm3). The ablation speed was calculated by dividing the stone volume (mm3) by the lasing time (seconds). Patients with a stone size <4 mm were deemed stone-free. Results: The MOSES and TFL groups comprised 62 and 49 patients, respectively. There were no significant differences between groups for baseline patient demographics or stone characteristics. The two modalities had comparable total energy, laser time, efficacy, and ablation speeds. No differences were detected in stone-free rates or complications between both groups. When dealing with calcium phosphate stones, we observed that the lasing time was significantly shorter with MOSES than TFL (7.95 vs 10.85 minutes, respectively [p = 0.01]). Conclusions: MOSES and TFL laser systems had comparable efficacy for lithotripsy of renal calculi during f-URS; however, calcium phosphate stones had a longer lasing time with TFL. REB Number: 100210.
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.
Comparing outcomes of thulium fiber laser versus high-power Holmium:YAG laser lithotripsy in pediatric patients managed with RIRS for kidney stones. A multicenter retrospective study. [2023]The aim of this study was to evaluate thulium fiber laser (TFL) safety and efficacy compared to high-power (HP) Holmium:YAG laser in pediatric patients who have undergone retrograde intrarenal surgery (RIRS) for kidney stones.
[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. [2021]The SuperPulse Thulium (Tm) fiber laser (wavelength of 1.94 m) has been recently introduced as a directed-energy source for urology. Preclinical studies have shown a significant potential of the SuperPulse Tm fiber laser (SP TFL) for lithotripsy. However, clinical reports of using SP TFL to treat urolithiasis are still few and limited. Of special interest are challenging cases, e.g., lower pole stones, when extreme deflection of the instrument is required.
Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. [2016]The experimental Thulium fiber laser (TFL) is currently being studied as a potential alternative lithotripter to the clinical gold standard Holmium:YAG laser. Safety studies characterizing undesirable Holmium:YAG laser-induced damage to ureter tissue and stone baskets have been previously reported. Similarly, this study characterizes TFL induced ureter and stone basket damage.