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Transperineal Laser Ablation for Treatment of Benign Prostatic Obstruction

NCT03653117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-21

No results posted yet for this study

Summary

Rationale: With age a large group of men experience lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). Standard treatment is a transurethral resection of the prostate or laser vaporization. As these techniques enter the prostate via the urethra, are invasive and require general or spinal anaesthesia. Transperineal laser ablation (TPLA) is a minimal invasive procedure, that can be performed under local anaesthesia.

Objective: The primary objective of this study is to prove feasibility and safety of TPLA for LUTS due to BPO in healthy men.

Secondary objectives: The secondary objectives are to determine functional voiding, erectile outcomes and changes on imaging.

Conditions

  • Prostatic Hyperplasia, Benign

Interventions

DEVICE

Transperineal laser ablation

Minimal invasive coagulation of prostatic tissue by laser

Sponsors & Collaborators

  • Elesta S.R.L.

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2022-05-23
Completion
2022-05-23

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653117 on ClinicalTrials.gov