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

NCT ID: NCT03353571

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.

This single arm, prospective study is designed to produce valid scientific evidence regarding:

1. 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.
2. 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.

The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.

Conditions

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Urinary Retention Urinary Bladder, Neurogenic Intermittent Catheterization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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C3 PATIENT PARTICIPANTS

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.

Group Type OTHER

C3 "UMBRELLA CATHETER"

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with Bladder Dysfunction requiring mechanical drainage.
2. Patients with actual urinary retention

Exclusion Criteria

1. Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
2. Gross hematuria
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Gaines W. Hammond Jr. MD FACS

INDIV

Sponsor Role lead

Responsible Party

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Dr. Gaines W. Hammond Jr. MD FACS

SPONSOR- INVESTIGATOR

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Watson Clinic Llp

Lakeland, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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GAINES W HAMMOND, MD

Role: CONTACT

Phone: 863-680-7300

Email: [email protected]

ELAYNE HALL

Role: CONTACT

Phone: 863-680-7300

Email: [email protected]

Facility Contacts

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GAINES W HAMMOND, MD

Role: primary

ELAYNE HALL

Role: backup

Other Identifiers

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Study # 17/30/08

Identifier Type: -

Identifier Source: org_study_id