Benign Prostatic HypertrophyNCT05308017
Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP
A study testing Richard Wolf 24F Laser scope and Karl Storz 28F Laser Scope in people with Benign Prostatic Hypertrophy, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters). Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Richard Wolf 24F Laser scope and Karl Storz 28F Laser Scope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 29 Sep 2023
- 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 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms
Who cannot join
- Patients who lack decisional capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate
The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Richard Wolf 24F Laser scope, Karl Storz 28F Laser Scope
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Richard Wolf 24F Laser scopeDevice
24F Laser with HoLEP
Karl Storz 28F Laser ScopeDevice
28 F Laser with HoLEP
| Study group | Role | What they receive |
|---|---|---|
| Richard Wolf 24F Laser scope | Active comparator | Not described Receives: Device: Richard Wolf 24F Laser scope |
| Karl Storz 28F Laser scope | Active comparator | Not described Receives: Device: Karl Storz 28F Laser Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Time difference between the 24F laser scope and the 28F laser scope
comparing operative time between the 24F and the 28F laser scope groups.
Measured: Day 0
Secondary outcomes (3)
Surgeon evaluation of Laser scopes flow rate
Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
- How was the flow through the scope?
- 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good
Measured: Day 0
Surgeon evaluation of Laser scope visualization
Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
- How was the visualization?
- 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good
Measured: Day 0
Surgeon evaluation of Laser scope bladder injury
Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
- Did bladder injury occur?
- 1) Yes 2) No
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 May 2022
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Model description
- randomized to one of two different types of scopes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308017
- Sponsor's protocol ID
- STU00215646
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dean NS, Lee MS, Assmus MA, Guo J, Xu P, McDonald A, Fadl-Alla A, Helin J, Krambeck AE. Does Resectoscope Sheath Size Influence Holmium Laser Enucleation of the Prostate Outcomes? A Prospective Randomized Controlled Trial. J Endourol. 2023 Dec;37(12):1261-1269. doi: 10.1089/end.2023.0383.
PubMed 37786336
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate
- ClinicalTrials.gov ID
- NCT05308017
- Acronym / sponsor ID
- STU00215646
- Conditions
- Benign Prostatic Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 1 Apr 2022 (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.
The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized to one of two different types of scopes.
| Arm | Type | Receives |
|---|---|---|
| Richard Wolf 24F Laser scope | Active comparator | Device: Richard Wolf 24F Laser scope |
| Karl Storz 28F Laser scope | Active comparator | Device: Karl Storz 28F Laser Scope |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms
Key exclusion criteria (1 listed)
- Patients who lack decisional capacity
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 |
|---|---|---|
| Richard Wolf 24F Laser scope24F Laser with HoLEP | Device | Richard Wolf 24F Laser scope |
| Karl Storz 28F Laser Scope28 F Laser with HoLEP | Device | Karl Storz 28F Laser scope |
Primary outcome
Surgery Time difference between the 24F laser scope and the 28F laser scope
Time frame: Day 0
comparing operative time between the 24F and the 28F laser scope groups.
3 secondary outcomes
Surgeon evaluation of Laser scopes flow rate
Time frame: Day 0
Surgeon evaluation of Laser scope visualization
Time frame: Day 0
Surgeon evaluation of Laser scope bladder injury
Time frame: Day 0
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 20 Mar 2024.
- Derived from this study: PubMed 37786336Dean NS, Lee MS, Assmus MA, Guo J, Xu P, McDonald A, Fadl-Alla A, Helin J, Krambeck AE. Does Resectoscope Sheath Size Influence Holmium Laser Enucleation of the Prostate Outcomes? A Prospective Randomized Controlled Trial. J Endourol. 2023 Dec;37(12):1261-1269. doi: 10.1089/end.2023.0383.
- Individual participant dataSharing planned: No
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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 Richard Wolf 24F Laser scope and Karl Storz 28F Laser Scope in people with Benign Prostatic Hypertrophy, run by Northwestern University 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 1 inclusion and 1 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 20 Mar 2024. 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?
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?
Surgery Time difference between the 24F laser scope and the 28F laser scope (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05308017, which also lists 1 linked publication.
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 20 Mar 2024.