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

Primary Purpose

Benign Prostatic Hypertrophy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Richard Wolf 24F Laser scope

Karl Storz 28F Laser Scope

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients who lack decisional capacity

Sites / Locations

Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Richard Wolf 24F Laser scope

Karl Storz 28F Laser scope

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Surgeon evaluation of Laser scopes flow rate

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 1) How was the flow through the scope? a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good

Surgeon evaluation of Laser scope visualization

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 2) How was the visualization? a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good

Surgeon evaluation of Laser scope bladder injury

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 3) Did bladder injury occur? a. 1) Yes 2) No

Full Information

NCT ID

NCT05308017

First Posted

March 6, 2022

Last Updated

March 29, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05308017

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hypertrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized to one of two different types of scopes.

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Richard Wolf 24F Laser scope

Arm Type

Active Comparator

Arm Title

Karl Storz 28F Laser scope

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Richard Wolf 24F Laser scope

Intervention Description

24F Laser with HoLEP

Intervention Type

Device

Intervention Name(s)

Karl Storz 28F Laser Scope

Intervention Description

28 F Laser with HoLEP

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

Surgeon evaluation of Laser scopes flow rate

Description

Time Frame

Day 0

Title

Surgeon evaluation of Laser scope visualization

Description

Time Frame

Day 0

Title

Surgeon evaluation of Laser scope bladder injury

Description

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 3) Did bladder injury occur? a. 1) Yes 2) No

Time Frame

Day 0

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male only

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms Exclusion Criteria: Patients who lack decisional capacity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Helon

Phone

312-908-8145

jessica.helon@northwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Matt Lee

matt.lee1@northwestern.edu

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Helon

jessica.helon@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Alyssa McDonald

alyssa.mcdonald@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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