Direct Costs Excluding Capital Equipment PurchaseNCT03495258
Prostate Vaporization Techniques in Canadian Hospital
A study testing Clarion Evolve Laser Vaporization System and Olympus TURis Plasma Vaporization in people with Direct Costs Excluding Capital Equipment Purchase and Operator (Surgeon) Completed Questionnaire, run by Queen's University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Direct Costs Excluding Capital Equipment Purchase, Operator (Surgeon) Completed Questionnaire, Operative Parameters (Time, Bleeding Etc)
- What is being tested?
- Clarion Evolve Laser Vaporization System and Olympus TURis Plasma Vaporization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to 8 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Technology Assessment Trial of Prostate Vaporization Techniques in a Canadian Hospital
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.
Read the 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.
- 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)
- Being tested
- Clarion Evolve Laser Vaporization System, Olympus TURis Plasma Vaporization
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarion Evolve Laser Vaporization SystemProcedure or surgery
Olympus TURis Plasma VaporizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Clarion Evolve Laser Vaporization System | Experimental | Clarion Evolve Laser Vaporization System Receives: Procedure: Clarion Evolve Laser Vaporization System |
| Olympus TURis Plasma Vaporization | Experimental | Olympus TURis Plasma Vaporization Receives: Procedure: Olympus TURis Plasma Vaporization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarion laser vaporization of the prostate
Clarion laser vaporization of the prostate
Measured: 3 months
Olympus plasma vaporization of the prostate
Olympus plasma vaporization of the prostate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study startMay 2014
- Primary completion8 Jul 2016
- Study completion8 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Costs Excluding Capital Equipment PurchaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. J. Curtis Nickel, Queen's University
- Investigators
- Curtis Nickel, MD FRCSC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495258
- Sponsor's protocol ID
- Vaporization
- Status last verified
- Apr 2018
- First submitted
- 10 Jun 2014
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Technology Assessment Trial of Prostate Vaporization Techniques in a Canadian Hospital
- ClinicalTrials.gov ID
- NCT03495258
- Acronym / sponsor ID
- Vaporization
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 8 Jul 2016 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarion Evolve Laser Vaporization System | Experimental | Procedure: Clarion Evolve Laser Vaporization SystemClarion Evolve Laser Vaporization System |
| Olympus TURis Plasma Vaporization | Experimental | Procedure: Olympus TURis Plasma VaporizationOlympus TURis Plasma Vaporization |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarion Evolve Laser Vaporization System | Procedure or surgery | Clarion Evolve Laser Vaporization System |
| Olympus TURis Plasma Vaporization | Procedure or surgery | Olympus TURis Plasma Vaporization |
Primary outcome
Clarion laser vaporization of the prostate
Time frame: 3 months
Clarion laser vaporization of the prostate
Olympus plasma vaporization of the prostate
Time frame: 3 months
Olympus plasma vaporization of the prostate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis Nickel, MD FRCSC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarion Evolve Laser Vaporization System and Olympus TURis Plasma Vaporization in people with Direct Costs Excluding Capital Equipment Purchase and Operator (Surgeon) Completed Questionnaire, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarion laser vaporization of the prostate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.