The first patient has been enrolled in a real-world study of the Soltive SuperPulsed Laser System (Soltive Laser System), which uses thulium fiber laser technology to break up kidney and ureteral stones.1
The Soltive Laser System has US FDA 510(k) clearance and clinical trial evidence has shown that the system generated finer particulate and dusted stones in half the time as a standard holmium yttrium aluminium garnet (Ho:YAG) laser.2 Among other benefits, the Soltive Laser System has also demonstrated an infinitesimal level of retropulsion.
The first patient in the real-world study was treated by Wilson Molina, MD, professor of Urology at the University of Kansas School of Medicine.
“As one of the first physicians to test this new technology, I am thrilled to have treated the first patient as part of this important study,” Molina stated in a press release. “The Soltive Laser System is silent, portable, and user friendly, and it performs wonderfully. I can’t think about any clinical scenario for intracorporeal lithotripsy that can’t be managed with this system.”
The post-market, single-group assignment, open-label, registry study aims to enroll 450 adult patients medically indicated for ureteroscopy, percutaneous nephrolithotomy (PCNL), or mini PCNL. Study sites will include up to 5 centers in the United States, 3 centers in Europe, and 1 center in Canada.
The goal of the study is to establish real-world efficacy evidence of using the Soltive Laser System for laser lithotripsy. The primary end point is the stone-free rate at 3 months posttreatment. Secondary end points include total laser energy time, total procedure time, accessory devices used, and safety. The estimated primary completion date for the study is October 26, 2020.
Data were previously reported for a pivotal trial of the Soltive Laser System in 268 patients with stone disease, including 173 kidney, 80 ureteral, and 15 bladder.2 The average stone size was 11.4 mm (range, 7-25) for kidney, 7.6 mm (range, 3-18) for ureteral, and 22.2 mm (range, 9-36) for bladder. The average stone density was 987 HU (range, 330-1960), 995 HU (range, 460-1700), and 980 HU (range, 860-1050), respectively.
Regarding the time to complete stone fragmentation (to dust or small fragments), the average time was 27.2 minutes for renal stones, 17.1 minutes for ureteral stones, and 19 minutes for bladder stones. The investigators observed that the retropulsion was insignificant in all cases with energy level less than 0.5 J. In most cases, surgeons estimated visibility as optimal.
There were no major safety issues with the Soltive Laser System. The investigators did not observe any optic or working channel damages, or urinary tract injuries. Further, no grade ≥IIIa complications (Clavien-Dindo) were reported.
“This new laser is exciting because it is going to change the way we treat stones. With a completely different way of delivering the laser energy to the stone, we are now able to fragment stones very quickly and into much smaller pieces, like the fine sand you’d find at a white sandy beach,” Ben Chew, MD, MSc, associate professor in the Department of Urologic Sciences at the University of British Columbia in Vancouver and co-principal investigator of the trial, stated in a press release.
“With Soltive, urologists may be able to treat bigger stones endoscopically, which means we can avoid having to access the kidney through an incision in the patient’s back. Patients and physicians benefit because the procedure is more efficient, and the technique for treatment is much less involved,” added Chew.
1. First Patient Enrolled in Olympus Study of the SOLTIVE Laser System. Published online December 18, 2020. https://bit.ly/2JT7mGy. Accessed January 7, 2021.
2. Traxer O, Dymov A, Rapoport L, et al. Comprehensive clinical study of super pulse tm fiber laser for treatment of stone disease. J Urol. 2019;201(supplement 4). https://doi.org/10.1097/01.JU.0000555074.09285.c7