BPHNCT04826887
SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
An observational study of BPH and Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- BPH, Benign Prostatic Hyperplasia
- What is being tested?
- SOLTIVE Thulium Laser
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2021to 2 May 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will present to clinic for treatment of BPH assessment and evaluation per routine clinical care. Patients will be identified by clinical care team as an eligible candidate for study participation.
Who may be able to join
- Patients must be 18 years of age or older
- Patients must be diagnosed with benign prostatic hyperplasia
- Patients must opt for surgical management of their BPH with laser enucleation
Who cannot join
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- Patients with prostate glands greater or equal to 200 grams
- Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medcial Center
Kansas City, Kansas, 66160
About this study
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.
Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations
Read the detailed description
Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.
- Conditions
- BPH, Benign Prostatic Hyperplasia
- Being tested
- SOLTIVE Thulium Laser, Standard of Care (Holmium Laser)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLTIVE Thulium LaserOther
Use of SOLTIVE Thulium laser for HoLEP
Standard of Care (Holmium Laser)Other
Use of Holmium laser for HoLEP
| Study group | Role | What they receive |
|---|---|---|
| Solep Arm | Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure Receives: Other: SOLTIVE Thulium Laser | |
| Control Arm | Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure Receives: Other: Standard of Care (Holmium Laser) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP
To evaluate SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) in comparison to Holmium Laser Enucleation of the Prostate through AUA Symptom Score. AUA Symptom score will be assessed using the Scale - Mild (under 7 cumulative score, moderate 8-19 score, and severe is a cumulative score over 20).
Measured: up to 1 year
Secondary outcomes (2)
Compare intraoperative components between the two surgical approaches
To compare intraoperative components of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate
Measured: up to 1 year
Compare post-operative outcomes of the two surgical approaches
To compare post-operative components of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start14 Apr 2021
- Primary completion30 Nov 2022
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Neff, MD, FACS, University of Kansas Medical Center
- Investigators
- Donald Neff, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826887
- Sponsor's protocol ID
- GU-EN-Solep-01
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04826887
- Acronym / sponsor ID
- GU-EN-Solep-01
- Conditions
- BPH, Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 1 Apr 2021 (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.
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.
Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations
Detailed description
Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solep Arm | – | Other: SOLTIVE Thulium LaserUse of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure |
| Control Arm | – | Other: Standard of Care (Holmium Laser)Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will present to clinic for treatment of BPH assessment and evaluation per routine clinical care. Patients will be identified by clinical care team as an eligible candidate for study participation.
Key inclusion criteria (3 listed)
- Patients must be 18 years of age or older
- Patients must be diagnosed with benign prostatic hyperplasia
- Patients must opt for surgical management of their BPH with laser enucleation
Key exclusion criteria (3 listed)
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- Patients with prostate glands greater or equal to 200 grams
- Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
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 |
|---|---|---|
| SOLTIVE Thulium LaserUse of SOLTIVE Thulium laser for HoLEP | Other | Solep Arm |
| Standard of Care (Holmium Laser)Use of Holmium laser for HoLEP | Other | Control Arm |
Primary outcome
Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP
Time frame: up to 1 year
To evaluate SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) in comparison to Holmium Laser Enucleation of the Prostate through AUA Symptom Score. AUA Symptom score will be assessed using the Scale - Mild (under 7 cumulative score, moderate 8-19 score, and severe is a cumulative score over 20).
2 secondary outcomes
Compare intraoperative components between the two surgical approaches
Time frame: up to 1 year
Compare post-operative outcomes of the two surgical approaches
Time frame: up to 2 years
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 2 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for BPH
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
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.
Donald Neff principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH and Benign Prostatic Hyperplasia, run by University of Kansas Medical Center 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 3 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 2 Oct 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?
Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP (time frame: up to 1 year). 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 2 Oct 2024.