NCT05330598

Evaluation of the Safety and Clinical Performance of the Connected Catheter Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Spinal Singularity · Industry
• Sex: Male
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use. 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

UroDev Medical 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 4 weeks including weekly device exchange appointments. 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
• Chronic

Interventions

Type	Name	Description
DEVICE	Connected Catheter	The Connected Catheter System is a replaceable wireless urinary prosthesis that is indicated for bladder emptying in male patients who have impaired bladder emptying due to chronic Urinary Retention. The Connected Catheter resides fully internally in the male lower urinary tract (urethra and bladder neck) and remains in place for up to 7 days before removal.

Timeline

• Start date: 2022-01-27
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-04-15
• Last updated: 2024-02-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study