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Prostate Vaporization Techniques in Canadian Hospital

NCT03495258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2018-04-13

No results posted yet for this study

Summary

Kingston General Hospital is committed to upgrading the surgical treatment platform for benign prostate surgery. Vaporization Surgery, either laser-vaporization or electo-vaporization is becoming a "standard" of therapy for benign prostatic hyperplasia rather than the traditional transurethral resection of the prostate. However many Canadian hospitals have been slow to adopt an updated program because of evolving competing technology systems as well as unknown cost, efficacy, complication and patient/surgeon satisfaction considerations. KGH has been recognized as a centre of excellence in evaluating medical therapy for BPH and studies from the institution have impacted BPH care nationally and abroad. Laser and other state of the art BPH surgical technologies are being purchased by Ontario hospitals, including the local area, with no prospective assessment process. Kingston is uniquely advantaged to undertake a randomized comparative study of two of the most promising technology platforms because the investigators have the experience and expertise to perform the study in a hospital and surgeon naive institution.

The investigators propose to directly compare two vaporization techniques, laser and plasma vaporization systems. The investigators will be able to answer the most important questions in technology introduction and technique into our hospital system - cost, efficacy, safety and satisfaction. The results will inform KGH (and other similar Ontario centres) on the advantage or not (financial and patient care related) of investing in a BPH state of the art vaporization technology.

Conditions

  • Direct Costs Excluding Capital Equipment Purchase
  • Operator (Surgeon) Completed Questionnaire
  • Operative Parameters (Time, Bleeding Etc)
  • Complications (Post-op Retention, Bleeding, Re-admission to Hospital, Infection Etc)
  • 3 Month Efficacy Evaluation (Compared to Baseline) Using Validated Symptom Assessment Tools (See Outcome Metrics for Details)

Interventions

PROCEDURE

Clarion Evolve Laser Vaporization System

PROCEDURE

Olympus TURis Plasma Vaporization

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Curtis Nickel, MD FRCSC · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-07-08
Completion
2016-07-08

Countries

  • Canada

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 NCT03495258 on ClinicalTrials.gov