An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02979808|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neurogenic Bowel||Device: Navina Smart||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
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.
- 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.
- 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)
- 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
- 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).
- 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.
- Frequency of urinary tract infection (UTI). [ Time Frame: 3-months and 12-months ]Investigate frequency of UTI using patient reported outcome (PRO) variables.
- Health economic analysis utilizing QoL data. [ Time Frame: Baseline, 3-months, and 12-months. ]To perform health economic analyses using QoL data (EQ-5D).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979808
|Contact: Susanne Lindholm||+46 31 376 45 03||Susanne.firstname.lastname@example.org|
|Contact: Anton Emmanuel, Dr.||email@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Peter Christensen, Prof. firstname.lastname@example.org|
|Hôpital St Jacques||Recruiting|
|Nantes, Rennes, France, 44093|
|Contact: Brigitte Perrouin-Verbe, Prof. email@example.com|
|Zentralklinik Bad Berka Gmbh||Recruiting|
|Bad Berka, Germany, 99437|
|Contact: Ines Kurze, Dr. firstname.lastname@example.org|
|Hamburg, Germany, 21033|
|Contact: Ralf Bothig, Dr.|
|Montecatone Rehabilitation Institute, Università di Bologna||Recruiting|
|Imola, Bologna, Italy, 40026|
|Contact: Gabriele Bazzocchi, Prof. email@example.com|
|Contact: Gabriele Bazzocchi, Prof. firstname.lastname@example.org|
|Azienda Ospedaliera- Universitaria Careggi||Recruiting|
|Firenze, Florence, Italy, 50134|
|Contact: Giulio Del Popolo, Dr. email@example.com|
|Sunnaas Sykehus HF||Recruiting|
|Nesoddtangen, Norway, 1450|
|Contact: Thomas Glott, Dr. firstname.lastname@example.org|
|Unidad de Lesionados Medulares Hospital Traumatología||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Gonzalez Viejo, Dr. email@example.com|
|Complejo Hospitalario Universitario A Coruña||Recruiting|
|Coruna, Spain, 15006|
|Contact: Maria E Ferreiro, Dr. MA.Elena.Ferreiro.Velasco@sergas.es|
|Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna||Recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Claes Hultling, Prof. firstname.lastname@example.org|
|Gastrointestinal Physiology Unit, University College London Hospital||Recruiting|
|London, United Kingdom, NW1 2BU|
|Contact: Anton Emmanuel, Prof. email@example.com|