An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

December 11, 2019 updated by: Dentsply International
This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
  • France
    • Rennes
      • Nantes, Rennes, France, 44093
        • Hôpital St Jacques
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Hamburg, Germany, 21033
        • BG-Klinikum Hamburg
  • Italy
    • Bologna
      • Imola, Bologna, Italy, 40026
        • Montecatone Rehabilitation Institute, Università di Bologna
    • Florence
      • Firenze, Florence, Italy, 50134
        • Azienda Ospedaliera- Universitaria Careggi
  • Norway
      • Nesoddtangen, Norway, 1450
        • Sunnaas Sykehus HF
  • Spain
      • Barcelona, Spain, 08035
        • Unidad de Lesionados Medulares Hospital Traumatología
      • Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
  • Sweden
      • Stockholm, Sweden, 171 76
        • Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • Gastrointestinal Physiology Unit, University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of informed consent.
  2. Male or female aged 18 years or older.

  3. Patient with previously confirmed chronic spinal cord injury, either:

    1. Traumatic; at any level and any completeness of injury and ASIA grade classification, or
    2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.
  4. At least 3 months post spinal cord injury at time of consent.
  5. NBD score ≥10, confirmed at Baseline .
  6. Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).
  7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.
  8. Able to handle smartphone/tablet.

Exclusion Criteria:

  1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
  2. Untreated rectal impaction.
  3. Any radiotherapy to the pelvis.
  4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).
  5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment).
  6. Current use of prokinetics.
  7. Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision).
  8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
  9. Overt or planned pregnancy.
  10. Ongoing symptomatic UTI as judged by investigator.
  11. Diagnosed psychiatric illness, considered as unstable by the investigator.
  12. Diagnosed with MS.
  13. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
  14. Previous enrolment in the present study.
  15. Simultaneous participation in another clinical study that may interfere with the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Navina Smart
Navina Smart will be used during 12 months for transanal irrigation (TAI).
Device: Navina Smart
Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in neurogenic bowel disfunction symptoms.
Time Frame: 3 months
1. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of QoL status
Time Frame: Baseline, 3-months, 12-months
To investigate the change of QoL status in the selected patient population (absolute values)
Baseline, 3-months, 12-months
NBD symptoms
Time Frame: 6-months, 9-months, 12-months
To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
6-months, 9-months, 12-months
Product use compliance.
Time Frame: 3-months, 6-months, 9-months, and 12-months
Study product use compliance (is TAI still performed using the study device).
3-months, 6-months, 9-months, and 12-months
Patient satisfaction assessed through patient reported outcome (PRO) variables.
Time Frame: 3-months and 12-months
To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
3-months and 12-months
Frequency of urinary tract infection (UTI).
Time Frame: 3-months and 12-months
Investigate frequency of UTI using patient reported outcome (PRO) variables.
3-months and 12-months
Health economic analysis utilizing QoL data.
Time Frame: Baseline, 3-months, and 12-months.
To perform health economic analyses using QoL data (EQ-5D).
Baseline, 3-months, and 12-months.
Health economic analysis utilizing patient reported outcome (PRO) variables.
Time Frame: Baseline, 3-months, and 12-months.
To perform health economic analyses using PRO variables.
Baseline, 3-months, and 12-months.
Thematic analysis of interview data.
Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period).
To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.
Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period).
To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.
Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period).
To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
Baseline, 3-months, and 12-months (or at end of treatment period).
Incidence of adverse events, serious adverse events, and adverse device effects.
Time Frame: 3-months, 6-months, 9-months, 12-months
To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.
3-months, 6-months, 9-months, 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dentsply International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wellspect HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAV-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings