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

NCT03353571 | Unknown FDA Device

• 1 other identifier: Study # 17/30/08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Catheterization of the bladder from an antegrade direction with the C3 device.

  The percentage for patients enrolled in the student with the C3 inserted who are able to engage the tubular portion of the device into the bladder neck and urethra from the default position in the bladder with resultant drainage of the bladdder.

  Measurement of data points are collected sequentially every 7 days up to 28 days.

• The retreat of the C3 back into the bladder from the engaged position

  The percentage of enrolled patients who upon completion of bladder drainage with the engaged tubular portion of the C3 in bladder neck and urethral location retreats back into the default position in the bladder.

  Measurement of data points are collected sequentially every 7 days up to 28 days.

Secondary Outcomes (1)

• Reduction in Catheter Acquired Urinary Tract Infection Rate

  Measurement of data points are collected sequentially every 7 days up to 28 days.

Study Arms (1)

C3 PATIENT PARTICIPANTS

OTHER

This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the C3 in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days in patients. The total study population will initially include 50 subjects with open enrollment of additional subjects.

Device: C3 "UMBRELLA CATHETER"

Interventions

C3 "UMBRELLA CATHETER" DEVICE

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.

C3 PATIENT PARTICIPANTS

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Bladder Dysfunction requiring mechanical drainage.
• Patients with actual urinary retention

You may not qualify if:

• Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
• Gross hematuria

Sponsors & Collaborators

• Dr. Gaines W. Hammond Jr. MD FACS: lead

Study Sites (1)

Watson Clinic Llp

Lakeland, Florida, 33805, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

GAINES W HAMMOND, MD

CONTACT

863-680-7300; GHAMMOND@WATSONCLINIC.COM

ELAYNE HALL

CONTACT

863-680-7300; EHALL@WATSONCLINIC.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SPONSOR- INVESTIGATOR

Model Details: Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days. The reduction in Catheter Acquired Urinary Tract Infection (CAUTI) A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 27, 2017
• Study Start: August 31, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After completion of the study which is anticipated to be March 2018 for a period of 2 years post completion.
• Access Criteria: Access with proper credentials with the patient identifying markers withheld.

Locations

US (1)