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Clinical Trial Summary

To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations


Clinical Trial Description

Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04826887
Study type Observational [Patient Registry]
Source University of Kansas Medical Center
Contact
Status Enrolling by invitation
Phase
Start date April 29, 2021
Completion date December 31, 2023

See also
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