Benign Prostatic Hypertrophy Requiring Surgical InterventionNCT02195622
Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
A study testing Lumenis VersaCut Morcellator and Wolf Piranha Morcellator in people with Benign Prostatic Hypertrophy Requiring Surgical Intervention, run by Indiana Kidney Stone Institute at 1 site in United States.
Trial summary
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy Requiring Surgical Intervention
- What is being tested?
- Lumenis VersaCut Morcellator and Wolf Piranha Morcellator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- Able to give informed consent.
- Age 18 years or older
Who cannot join
- • Inability to give informed consent.
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Physicians Urology
Indianapolis, Indiana, 46202
About this study
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).
Read the detailed description
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity.
A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure.
Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device
- Being tested
- Lumenis VersaCut Morcellator, Wolf Piranha Morcellator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenis VersaCut MorcellatorDevice
Wolf Piranha MorcellatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Lumenis VersaCut Morcellator | Other | Lumenis VersaCut Morcellator will be utilized for prostate tissue morcellation Receives: Device: Lumenis VersaCut Morcellator |
| Wolf Piranha Morcellator | Other | Wolf Piranha Morcellator will be utilized for prostate tissue morcellation Receives: Device: Wolf Piranha Morcellator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morcellation Rate
Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."
Measured: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic Hypertrophy Requiring Surgical InterventionStudies 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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Richard Wolf Medical Instruments Corporation (RWMIC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195622
- Sponsor's protocol ID
- 1305011478R001
- Status last verified
- Mar 2019
- First submitted
- 17 Jul 2014
- Last updated
- 11 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
- ClinicalTrials.gov ID
- NCT02195622
- Acronym / sponsor ID
- 1305011478R001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- Richard Wolf Medical Instruments Corporation (RWMIC)
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).
Detailed description
Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity.
A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure.
Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumenis VersaCut Morcellator | Other | Device: Lumenis VersaCut MorcellatorLumenis VersaCut Morcellator will be utilized for prostate tissue morcellation |
| Wolf Piranha Morcellator | Other | Device: Wolf Piranha MorcellatorWolf Piranha Morcellator will be utilized for prostate tissue morcellation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
- Able to give informed consent.
- Age 18 years or older
Key exclusion criteria (2 listed)
- • Inability to give informed consent.
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 |
|---|---|---|
| Lumenis VersaCut Morcellator | Device | Lumenis VersaCut Morcellator |
| Wolf Piranha Morcellator | Device | Wolf Piranha Morcellator |
Primary outcome
Morcellation Rate
Time frame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as "morcellation rate."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenis VersaCut Morcellator and Wolf Piranha Morcellator in people with Benign Prostatic Hypertrophy Requiring Surgical Intervention, run by Indiana Kidney Stone Institute at 1 site in United States.
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 3 inclusion and 2 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 11 Mar 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morcellation Rate (time frame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth). 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 11 Mar 2019.