Trials / Unknown
UnknownNCT03595735
The Zenflow Spring System Safety, Performance and Effectiveness Study
The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Zenflow, Inc. · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Detailed 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 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 (60 months). Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (60 months), or until exited.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Zenflow Spring System | The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool. |
Timeline
- Start date
- 2018-06-21
- Primary completion
- 2020-12-30
- Completion
- 2024-03-30
- First posted
- 2018-07-23
- Last updated
- 2021-07-22
Locations
3 sites across 1 country: Mexico
Source: ClinicalTrials.gov record NCT03595735. Inclusion in this directory is not an endorsement.