Calyxo Publishes ASPIRE Clinical Trial Results 

Calyxo, Inc. has published the complete 30-day outcomes from the ASPIRE (ASPiration to Improve Renal Calculi Removal Effectiveness) clinical trial in the Journal of Endourology. 

The positive study results demonstrate that steerable ureteroscopic renal evacuation (SURE) using Calyxo’s CVAC Aspiration System delivered significantly higher clearance of kidney stones and significantly lower residual stone volume (RSV) compared with traditional ureteroscopy (URS)¹. 

ASPIRE was a multi-center, prospective, randomized, non-inferiority, controlled Level 1 trial. It was the first to utilize stone clearance and residual stone volume in a clinical trial and set a new level of rigor by using 1.25mm NCCT slices (instead of the typical 3-5mm slices) that increase the accuracy of stone volume measurement and the detection of RF. 

“The 30-day results from the ASPIRE study demonstrate that CVAC is highly effective across a broad range of stone sizes,” said Brian R. Matlaga, MD, MPH, Professor of Urology and Director, The Stephens Center for Stone Disease, at Johns Hopkins University School of Medicine and lead author on the publication. “This is especially noteworthy in that the CVAC System is the first aspiration technology to demonstrate high effectiveness that does not wane with larger baseline stone volumes. This is a distinct contrast to what we observe in conventional URS^2-5 or other suction-based technologies such as flexible and navigable sheaths (FANS), wherein effectiveness declines as baseline stone volume increases.^6,7”

101 patients across 11 U.S. institutions were treated with either SURE using the CVAC System or with URS between June 2021 and February 2023.

The study showed that SURE with the CVAC System achieved significantly superior stone clearance vs, URS at 30 days, with a mean reduction in stone volume of 97% for SURE vs. 93% for URS (p=0.036). Also, regression analysis showed that SURE maintained high stone clearance and low RSV regardless of baseline stone volume, whereas with URS, efficacy worsened with increasing baseline stone volume.

“The ASPIRE results published today add to a growing body of evidence showing that SURE with the CVAC System has significant efficacy advantages compared with URS and proves that more complete stone clearance is possible,” said Joe Catanese, PhD, President & Chief Executive Officer of Calyxo. “We believe the newly published data will advance kidney stone research and foster the growing enthusiasm for the CVAC System within the clinical community, as we continue to make SURE more broadly available to patients who need an effective and safe treatment for kidney stones.”

Data from the ASPIRE study were initially reported at the American Urological Association (AUA) Annual Meeting in May 2024⁸.

References:

1. Matlaga, BR. A Prospective, Randomized, Non-inferiority Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Compared to Standard Ureteroscopy (URS): 30 Day Results of the ASPIRE Study, J. Endourol 2024
2. Elbakary MR. Factors affecting use of flexible ureteroscope in large renal stones; stone size or stone composition. Urol Ann 2022; 14(4): 336-339
3. Huang JS, Xie J, Huang XJ, et al. Flexible ureteroscopy and laser lithotripsy for renal stones 2 cm or greater: a single institutional experience. Medicine 2020; 99:43(e22704)
4. Mozafarpour S, Hernandez N, Lipkin M, et al. Outcomes of ureteroscopy. Minerva Urol Nefrol 2016; 68(6): 560-569
5. Takazawa R, Kitayama S, Tsujii T. Appropriate kidney stone size for ureteroscopic lithotripsy: When to switch to a percutaneous approach. World J Nephrol 2015; 4(1): 111-117
6. Gauhar, Minerva Uroland Nephrol 2024 Oct; 76(5): 625-34
7. Gauhar, Eur Urol Focus 2024 May 23: S2405-4569
8. Matlaga B et al, PD10-04, 30-day Results of the Aspire Study; AUA 2024; J Urol 2024, https://www.auajournals.org/doi/10.1097/01.JU.0001008748.59024.cb.04.