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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate BPH (Benign Prostatic Hyperplasia)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
* Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
* No prior history of prostate cancer.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Kamal Omar

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed K Omar, Assistant professor

Role: CONTACT

+201066949454

Facility Contacts

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Mohamed k Omar, Assistant professor

Role: primary

+201066949454

Other Identifiers

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Enucleation of prostate

Identifier Type: -

Identifier Source: org_study_id

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