Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
NCT ID: NCT07020364
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-10-01
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bipolar Enucleation
Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation.
A single working element for bipolar enucleation
Device: A single working element compatible with both bipolar and laser modalities.
The bipolar energy will be used for cutting and coagulation during enucleation.
Laser Enucleation
Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
A single working element for laser enucleation
Device: A single working element compatible with both bipolar and laser modalities.
Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Interventions
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A single working element for bipolar enucleation
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 enucleation
Device: A single working element compatible with both bipolar and laser modalities.
Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Eligibility Criteria
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Inclusion Criteria
* Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
* No prior history of prostate cancer.
Exclusion Criteria
* Prior prostate surgeries.
* Coagulation disorders or patients on long-term anticoagulation therapy.
* Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.
50 Years
MALE
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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Mohamed Kamal Omar
Assistant professor
Locations
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Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Enucleation of prostate
Identifier Type: -
Identifier Source: org_study_id
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