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Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters

NCT ID: NCT03289117

Last Updated: 2017-10-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-17

Study Completion Date

2017-05-26

Brief Summary

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A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.

Detailed Description

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This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.

The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).

Conditions

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Urinary Catheters Retention, Urinary Incontinence, Urinary Anesthesia, Local

Keywords

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Urinary catheterization Gel installation Novel medical device Indwelling urinary catheter Long-term urinary catheter Male patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device.

Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Open label

Study Groups

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Novel gel installation device procedure

Catheter change with novel device.

Each subject will undergo catheter change with novel gel instillation device procedure

Group Type EXPERIMENTAL

Novel gel installation device procedure

Intervention Type DEVICE

Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device

Standard procedure

Catheter change with standard procedure.

Each subject will undergo catheter change with standard procedure

Group Type ACTIVE_COMPARATOR

Standard procedure

Intervention Type DEVICE

Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Interventions

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Novel gel installation device procedure

Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device

Intervention Type DEVICE

Standard procedure

Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
* The patient provides informed consent prior to any study specific procedures
* The patient is considered to benefit from participation in the clinical study

Exclusion Criteria

* The patient do not consent to participate in the study
* Trauma to urethra or bladder
* Infection to urethra or bladder
* Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Vinnova

OTHER_GOV

Sponsor Role collaborator

Innovation Skåne AB/ Sweden

UNKNOWN

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulf Malmqvist, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Studies Sweden - Forum South

Locations

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Skåne University Hospital - Urology clinic - Homecare unit

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2016 02 01 ver 1_1

Identifier Type: -

Identifier Source: org_study_id