Benign Prostatic HypertrophyNCT04398420
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
A study testing TVERP, TURis and HoLEP in people with Benign Prostatic Hypertrophy, run by Olympus Surgical Technologies Europe at 3 sites in China.
Trial summary
To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods. Read more about this study
- Who is it for?
- Ages 22 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- TVERP, TURis and HoLEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesChina
- Study dates
- 27 Aug 2020to 1 Aug 2022
- 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 22 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age older than 22 and younger than 75 years of age
- The patient should be a candidate for surgical treatment of bladder outlet obstruction.
- Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
- Prostate volume ˃30 and ≤80 ml
- PSA <4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
- IPSS ≥8 (moderate to severe)
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- Indications for TURIS
- maximum urinary flow (Qmax) <10ml/second
- A written informed consent signed by the patient (including patient's agreement to randomization and treatment).
Who cannot join
- Patients under anti-inflammatory or steroid therapy
- Patients under anti-coagulation at a level that could be exposed to a very high risk of complications based on a comprehensive pre-operatory evaluation.
- Renal insufficiency Serum creatinine (Scr) >1.5 x upper limit of normal (ULN); AST and ALT>2.5 x ULN;Total bilirubin >1.5 x ULN
- Previous neurogenic lower urinary tract dysfunction.
- Patients with urethral strictures
- Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery.
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- Concurrent participation in any other clinical study
- Any of the following within the 12 months prior to study: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- Previous bladder outlet surgery.
- A clinically significant acute illness.
- Intake of medication in which the principle investigator considers to preclude enrollment into the trial.
- Known disease of the central or peripheral nervous system.
- Any clinical evidence of carcinoma of the prostate.
- HIV positive or any other immunosuppressive disorder.
- Psychological/psychiatric disease /Known cognitive disorder.
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital, Sichuan University
Chengdu, Sichuan, 310003
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Renmin Hospital,Wuhan University
Wuhan, Hubei, 430060
About this study
Official title: Safety and Efficacy of TVERP in BPH Patients With Prostate Size ˃30 and ≤80 ml: a Comparison Study Between TVERP With the Plasma Vaporisation Button, Bipolar TURis and HoLEP Treatments.
To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- TVERP, TURis, HoLEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVERPDevice
Transurethral Vapor Enucleation Resection of the prostate
TURisDevice
Transurethral Vapor Enucleation Resection of the prostate
HoLEPDevice
Transurethral Vapor Enucleation Resection of the prostate
| Study group | Role | What they receive |
|---|---|---|
| TVERP | Active comparator | Not described Receives: Device: TVERP |
| TURis | Active comparator | Not described Receives: Device: TURis |
| HoLEP | Active comparator | Not described Receives: Device: HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of blood level
Measured: Measurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start27 Aug 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Surgical Technologies Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398420
- Sponsor's protocol ID
- TVERP01
- Status last verified
- Jan 2023
- First submitted
- 12 May 2020
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TVERP in BPH Patients With Prostate Size ˃30 and ≤80 ml: a Comparison Study Between TVERP With the Plasma Vaporisation Button, Bipolar TURis and HoLEP Treatments.
- ClinicalTrials.gov ID
- NCT04398420
- Acronym / sponsor ID
- TVERP01
- Conditions
- Benign Prostatic Hypertrophy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Olympus Surgical Technologies EuropeIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 May 2020 (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 verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TVERP | Active comparator | Device: TVERP |
| TURis | Active comparator | Device: TURis |
| HoLEP | Active comparator | Device: HoLEP |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male, age older than 22 and younger than 75 years of age
- The patient should be a candidate for surgical treatment of bladder outlet obstruction.
- Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
- Prostate volume ˃30 and ≤80 ml
- PSA <4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
Key exclusion criteria (15 listed)
- Patients under anti-inflammatory or steroid therapy
- Patients under anti-coagulation at a level that could be exposed to a very high risk of complications based on a comprehensive pre-operatory evaluation.
- Renal insufficiency Serum creatinine (Scr) >1.5 x upper limit of normal (ULN); AST and ALT>2.5 x ULN;Total bilirubin >1.5 x ULN
- Previous neurogenic lower urinary tract dysfunction.
- Patients with urethral strictures
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 |
|---|---|---|
| TVERPTransurethral Vapor Enucleation Resection of the prostate | Device | TVERP |
| TURisTransurethral Vapor Enucleation Resection of the prostate | Device | TURis |
| HoLEPTransurethral Vapor Enucleation Resection of the prostate | Device | HoLEP |
Primary outcome
change of blood level
Time frame: Measurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed.
Results and safety
The study was stopped early (reason given: Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVERP, TURis and HoLEP in people with Benign Prostatic Hypertrophy, run by Olympus Surgical Technologies Europe at 3 sites in China.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 was stopped early (reason given: Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.). Results are not available in the source record.
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?
change of blood level (time frame: Measurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed.). 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 9 Jan 2023.