NCT04826887

SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• BPH
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
OTHER	SOLTIVE Thulium Laser	Use of SOLTIVE Thulium laser for HoLEP
OTHER	Standard of Care (Holmium Laser)	Use of Holmium laser for HoLEP

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-11-30
• Completion: 2024-05-02
• First posted: 2021-04-01
• Last updated: 2024-10-02

Locations

1 site across 1 country: United States