Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostate Vaporization Techniques in Canadian Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495258
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. J. Curtis Nickel, Queen's University

Brief 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.


Condition or disease Intervention/treatment Phase
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) Procedure: Clarion Evolve Laser Vaporization System Procedure: Olympus TURis Plasma Vaporization Not Applicable

Detailed Description:

To comparatively evaluate two state of the art vaporization techniques for transurethral prostatectomy, the Clarion Evolve Laser Vaporization System and the Olympus TURis Plasma Vaporization ("button" electrode) system. Both systems are approved for use by Health Canada for vaporization surgery of the prostate. Both techniques involve a vaporization ablation (laser and plasma mechanism respectively) of the prostate, rather than sequential excision (or cutting) of the prostate performed with our traditional TURP technique. Compared to a TURP, both of the two study techniques involve similar endoscopic access to the prostate, similar anesthetic requirements, similar post-operative catheterization but appear to differ in blood loss (less with vaporization techniques), hospital stay (inpatient stay for TURP compared to outpatient discharge for study techniques) and patient recovery (improved with proposed techniques).

The laser vaporization uses a dual wavelength (980 and 1470 nm) diode laser with a fibre that allows for contact vaporization ablation of the prostate. The hospital already uses a Clarion laser system for urinary stone lithotripsy. Clarion will provide the necessary equipment for this platform for the duration of the trial. The plasma vaporization uses a bipolar high frequency generator for vaporization and coagulation. The procedure is performed using a near-contact hovering technique and the tissue removal process is performed in a similar fashion as TURP. The hospital has recently purchased the Olympus platform and the extra equipment required for this study will be provided by Olympus for the study. These technology systems will be compared in a randomized single blinded controlled study in a "technology naive" hospital with "technology naive" surgeons. The primary outcome will be cost with satisfaction, efficacy, learning curve and safety as key outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Technology Assessment Trial of Prostate Vaporization Techniques in a Canadian Hospital
Study Start Date : May 2014
Actual Primary Completion Date : July 8, 2016
Actual Study Completion Date : July 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clarion Evolve Laser Vaporization System
Clarion Evolve Laser Vaporization System
Procedure: Clarion Evolve Laser Vaporization System
Experimental: Olympus TURis Plasma Vaporization
Olympus TURis Plasma Vaporization
Procedure: Olympus TURis Plasma Vaporization



Primary Outcome Measures :
  1. Clarion laser vaporization of the prostate [ Time Frame: 3 months ]
    Clarion laser vaporization of the prostate

  2. Olympus plasma vaporization of the prostate [ Time Frame: 3 months ]
    Olympus plasma vaporization of the prostate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male at least 45 years of age.
  • Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
  • IPPS symptom score ≥ 12 at screening visit.
  • Prostate volume on DRE estimated to be > 30cc.
  • Voluntarily signed informed consent agreement prior to the performance of any study procedures.

Exclusion Criteria:

  • Any prior invasive intervention for BPH.
  • PSA level greater than 10 ng/ml at screening without either a negative biopsy or documented explanation of why no biopsy was performed.
  • Medical condition unfit for surgery
  • History or current evidence of carcinoma of the prostate.
  • Documented bacterial prostatitis within the past 3 months.
  • Known severe bleeding disorder.
  • Unable to follow protocol directions or sign informed consent due to organic brain or psychiatric disease.
  • History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495258


Locations
Layout table for location information
Canada, Ontario
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7
Sponsors and Collaborators
Queen's University
Investigators
Layout table for investigator information
Principal Investigator: Curtis Nickel, MD FRCSC Queen's University
Layout table for additonal information
Responsible Party: Dr. J. Curtis Nickel, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT03495258    
Other Study ID Numbers: Vaporization
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes