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Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

NCT06068790 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-09

No results posted yet for this study

Summary

The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Conditions

Interventions

PROCEDURE

HoLEP Surgery

HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.

DEVICE

28 French sized rigid sheath

The 28Fr is the standard of care sheath size used at this site.

DEVICE

22 French sized rigid sheath

The 22Fr is the smaller, investigational sheath size to be used in this study.

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Marcelino Rivera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-12-30
Completion
2023-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06068790 on ClinicalTrials.gov