SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Status Enrolling by invitation

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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04807296` - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)	N/A
Recruiting	`NCT05574244` - Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction	N/A
Recruiting	`NCT04288427` - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy	N/A
Not yet recruiting	`NCT04245566` - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH	Phase 3
Completed	`NCT03246880` - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients	Phase 3
Withdrawn	`NCT01967251` - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction	Phase 2
Completed	`NCT02509975` - Safety and Efficacy of OCL 503 in Prostate Artery Embolization	N/A
Completed	`NCT02206243` - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed	`NCT02283684` - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT	Phase 4
Completed	`NCT01454349` - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)	Phase 1/Phase 2
Completed	`NCT01438775` - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)	Phase 3
Completed	`NCT01139762` - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms	Phase 3
Completed	`NCT01152190` - A Study in Benign Prostatic Hyperplasia	Phase 3
Active, not recruiting	`NCT00400894` - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma	N/A
Completed	`NCT00701779` - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia	Phase 4
Completed	`NCT00224133` - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months	Phase 3
Unknown status	`NCT00381108` - Study of the Effects of Pomegranate Tablets on Enlarged Prostates	Phase 1
Terminated	`NCT02962674` - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.	N/A
Active, not recruiting	`NCT05415748` - Deprescribing Tamsulosin in Older Men	Phase 4
Recruiting	`NCT04853914` - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.	N/A