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OpenTrials
Completed

NCT Number: NCT05308017

Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP

The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).

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Key information

Conditions

Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms

Exclusion criteria

  • Patients who lack decisional capacity

Treatment and study plan

Richard Wolf 24F Laser scope

Device

24F Laser with HoLEP

Karl Storz 28F Laser Scope

Device

28 F Laser with HoLEP

Primary outcomes

  1. Surgery Time difference between the 24F laser scope and the 28F laser scope

    Time frame: Day 0

    comparing operative time between the 24F and the 28F laser scope groups.

Secondary outcomes

  1. Surgeon evaluation of Laser scopes flow rate

    Time frame: Day 0

    Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery

    • How was the flow through the scope?

    a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good

  2. Surgeon evaluation of Laser scope visualization

    Time frame: Day 0

    Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery

    • How was the visualization?

    a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good

  3. Surgeon evaluation of Laser scope bladder injury

    Time frame: Day 0

    Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery

    • Did bladder injury occur?

    a. 1) Yes 2) No

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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