Spots Global Cancer Trial Database for Connected Catheter- Safety and Effectiveness Study
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Trial Identification
Brief Title: Connected Catheter- Safety and Effectiveness Study
Official Title: Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Study ID: NCT03843073
Interventions
Study Description
Brief Summary: The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
Detailed Description: Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
West Coast Urology, 11411 Brookshire Avenue, Suite 508, Downey, California, United States
West Coast Urology, 575 E. Hardy St., Suite 215, Inglewood, California, United States
Tri Valley Urology, 25495 Medical Center Dr., Suite 204, Murrieta, California, United States
Chesapeake Urology, Owings Mills, Maryland, United States
Minnesota Urology, 6025 Lake Road Suite 200, Woodbury, Minnesota, United States
New Jersey Urology, 15000 Midlantic Drive, Suite 100, Mount Laurel, New Jersey, United States
New Jersey Urology, 2401 Evesham Road, Suite F, Voorhees, New Jersey, United States
Dr. Jonathan Vapnek Urology, New York, New York, United States
Urology San Antonio, San Antonio, Texas, United States
Contact Details
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