NCT03843073

Connected Catheter- Safety and Effectiveness Study

Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Spinal Singularity · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Retention
• Neurogenic Bladder
• Urologic Diseases

Interventions

Type	Name	Description
DEVICE	Connected Urinary Catheter	Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Timeline

• Start date: 2020-10-16
• Primary completion: 2021-03-23
• Completion: 2021-04-06
• First posted: 2019-02-15
• Last updated: 2021-11-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study