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

NCT ID: NCT05308017

Last Updated: 2024-03-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized to one of two different types of scopes.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Richard Wolf 24F Laser scope

Group Type ACTIVE_COMPARATOR

Richard Wolf 24F Laser scope

Intervention Type DEVICE

24F Laser with HoLEP

Karl Storz 28F Laser scope

Group Type ACTIVE_COMPARATOR

Karl Storz 28F Laser Scope

Intervention Type DEVICE

28 F Laser with HoLEP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Richard Wolf 24F Laser scope

24F Laser with HoLEP

Intervention Type DEVICE

Karl Storz 28F Laser Scope

28 F Laser with HoLEP

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients who lack decisional capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amy Krambeck

Director of the Endourology/Stone Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Dean NS, Lee MS, Assmus MA, Guo J, Xu P, McDonald A, Fadl-Alla A, Helin J, Krambeck AE. Does Resectoscope Sheath Size Influence Holmium Laser Enucleation of the Prostate Outcomes? A Prospective Randomized Controlled Trial. J Endourol. 2023 Dec;37(12):1261-1269. doi: 10.1089/end.2023.0383.

Reference Type DERIVED
PMID: 37786336 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00215646

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.