A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:
• Male
• Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
• Subject is able and willing to comply with all the assessments of the study,
• Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
• ≥ 45 years of Age,
• Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
• The subject is indicated for undergoing HoLEP procedure
Locations
Other Locations
Chile
Hospital Clínico de la Universidad de Chile
RECRUITING
Santiago
Universidad Catolica de Chile
RECRUITING
Santiago
New Zealand
Tauranga Urology Research Limited
RECRUITING
Tauranga
Contact Information
Primary
Rami Abukhalil, MD. MPH
rami@andromedasurgical.com
513-808-2097
Backup
Michael Nketiah
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 54
Treatments
Experimental: A single-arm open label pilot study
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
Related Therapeutic Areas
Sponsors
Leads: Andromeda Surgical