ProstateNCT07020364
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
An observational study of Prostate and BPH (Benign Prostatic Hyperplasia), run by Menoufia University at 1 site in Egypt.
Trial summary
A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate, BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- A single working element for bipolar enucleation and A single working element for laser enucleation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.
Who may be able to join
- Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
- Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
- No prior history of prostate cancer.
Who cannot join
- Patients with ongoing urinary tract infections.
- Prior prostate surgeries.
- Coagulation disorders or patients on long-term anticoagulation therapy.
- Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, 13829
Mohamed k Omar, Assistant professor, +201066949454, kimo_81eg@yahoo.com
About this study
A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.
- Conditions
- Prostate, BPH (Benign Prostatic Hyperplasia)
- Being tested
- A single working element for bipolar enucleation, A single working element for laser enucleation
- Keywords
- laser enucleation, bipolar enucleation, BPH, prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single working element for bipolar enucleationDevice
Device: A single working element compatible with both bipolar and laser modalities.
The bipolar energy will be used for cutting and coagulation during enucleation.
A single working element for laser enucleationDevice
Device: A single working element compatible with both bipolar and laser modalities.
Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Enucleation | Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation. Receives: Device: A single working element for bipolar enucleation | |
| Laser Enucleation | Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis. Receives: Device: A single working element for laser enucleation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Measured: the operative time
Safety
intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).
Measured: 1 month
Secondary outcomes (2)
Efficacy
Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).
Measured: 1 month
Cost Analysis
Cost of using a single working element vs. standard separate tools for bipolar and laser.
Measured: the operative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Omar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020364
- Sponsor's protocol ID
- Enucleation of prostate
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT07020364
- Acronym / sponsor ID
- Enucleation of prostate
- Conditions
- Prostate, BPH (Benign Prostatic Hyperplasia)
- Keywords
- laser enucleation, bipolar enucleation, BPH, prostate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 Jun 2025 (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.
A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Enucleation | – | Device: A single working element for bipolar enucleationBipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation. |
| Laser Enucleation | – | Device: A single working element for laser enucleationLaser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.
Key inclusion criteria (3 listed)
- Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
- Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
- No prior history of prostate cancer.
Key exclusion criteria (4 listed)
- Patients with ongoing urinary tract infections.
- Prior prostate surgeries.
- Coagulation disorders or patients on long-term anticoagulation therapy.
- Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.
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 |
|---|---|---|
| A single working element for bipolar enucleationDevice: A single working element compatible with both bipolar and laser modalities. The bipolar energy will be used for cutting and coagulation during enucleation. | Device | Bipolar Enucleation |
| A single working element for laser enucleationDevice: A single working element compatible with both bipolar and laser modalities. Thulium or Holmium laser will be employed for tissue dissection and hemostasis. | Device | Laser Enucleation |
Primary outcome
Feasibility
Time frame: the operative time
Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Safety
Time frame: 1 month
intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).
2 secondary outcomes
Efficacy
Time frame: 1 month
Cost Analysis
Time frame: the operative time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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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.
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 Prostate and BPH (Benign Prostatic Hyperplasia), run by Menoufia University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed K Omar, Assistant professor (+201066949454, kimo_81eg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: the operative time). 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 Jun 2025.