Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07020364

Enrollment

Registered

2025-06-13

Start date

2024-10-01

Completion date

2025-11-01

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia), Prostate

Keywords

laser enucleation, bipolar enucleation, BPH, prostate

Brief 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.

Interventions

DEVICEA 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.

DEVICEA 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Feasibility	the operative time	Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Safety	1 month	intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).

Secondary

Measure	Time frame	Description
Efficacy	1 month	Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).
Cost Analysis	the operative time	Cost of using a single working element vs. standard separate tools for bipolar and laser.

Countries

Egypt

Contacts

Primary ContactMohamed K Omar, Assistant professor

kimo_81eg@yahoo.com+201066949454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026