Performance Evaluation of the AMS CONTINUUM™ Device

NCT00894933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-02-22

Study results available
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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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Entities

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 NCT00894933 on ClinicalTrials.gov