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A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."

NCT03353571 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-27

No results posted yet for this study

Summary

The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.

Conditions

  • Urinary Retention
  • Urinary Bladder, Neurogenic
  • Intermittent Catheterization

Interventions

DEVICE

C3 "UMBRELLA CATHETER"

The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder.

Sponsors & Collaborators

  • Dr. Gaines W. Hammond Jr. MD FACS

    lead INDIV

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03353571 on ClinicalTrials.gov