Performance Evaluation of the AMS CONTINUUM™ Device
NCT00894933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2018-02-22
Summary
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
Conditions
Interventions
- DEVICE
-
CONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Sponsors & Collaborators
-
American Medical Systems
lead INDUSTRY
Principal Investigators
-
Naveen Kella, MD · Urology San Antonio Research PA
-
John Libertino, MD · Lahey Clinic Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-12-31
- Completion
- 2010-12-31
Countries
- United States
Study Locations
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