Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Benign Prostatic Hyperplasia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multi-center, prospective, single-arm.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 45 years and 125 years
Gender
Only males

Description

A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2. Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpos...

A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2. Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2. Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (24 months). Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (24 months), or until exited.

Tracking Information

NCT #
NCT03595735
Collaborators
Not Provided
Investigators
Principal Investigator: Juan J Galan, MD Centro de Urología Avanzada del Noreste (CUAN)
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