Performance Evaluation of the AMS CONTINUUM™ Device

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00894933

Run by

American Medical Systems

People needed

33

Starts

2009-05-01

Expected to finish

2010-12-01

Last updated by the study team

2018-02-22

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study.
• The Subject is willing and able to return for study follow-up visits according to the protocol.
• The Subject can be off diuretics and blood thinners for at least one week prior to surgery.

You may not qualify if…

• If contraindicated for surgery
• Inability to understand the study or a history of non-compliance with medical advice
• Unwilling or unable to sign an Informed Consent Form (ICF)
• Participation in another clinical trial
• Previously implanted urological device
• A history of Recurrent urinary tract infections (UTI)
• A history of stricture disease
• Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy)
• Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)
• Uncontrolled insulin-dependent diabetes
• Chemotherapy within the past 6 months
• Non-topical steroid use within the past 6 months
• History of connective tissue or autoimmune conditions
• Compromised immune system
• Allergy to nitinol, nickel, titanium or silicone
• Body Mass Index greater than or equal to 30
• American Society of Anesthesiologists Score of > 3
• Prostate size greater than or equal to 50 grams as determined by TRUS

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Center for Urology — Rochester, New York, United States
• Urologic Consultants of Southeastern Pennsylvania — Philadelphia, Pennsylvania, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• Urology San Antonio Research PA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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