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| Name | Class |
|---|---|
| Wellspect HealthCare | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navina Smart | Experimental | Navina Smart will be used during 12 months for transanal irrigation (TAI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navina Smart | Device | Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurogenic bowel disfunction symptoms. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of QoL status | To investigate the change of QoL status in the selected patient population (absolute values) | Baseline, 3-months, 12-months |
| NBD symptoms | To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system |
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Inclusion Criteria:
Provision of informed consent.
Male or female aged 18 years or older.
Patient with previously confirmed chronic spinal cord injury, either:
At least 3 months post spinal cord injury at time of consent.
NBD score ≥10, confirmed at Baseline .
Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).
Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.
Able to handle smartphone/tablet.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| Hôpital St Jacques |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33513187 | Derived | Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, Bazzocchi G, Hultling C, Perrouin Verbe B, Bothig R, Glott T, Gonzalez Viejo MA. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453. doi: 10.1371/journal.pone.0245453. eCollection 2021. |
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| 6-months, 9-months, 12-months |
| Product use compliance. | 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. | 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). | Investigate frequency of UTI using patient reported outcome (PRO) variables. | 3-months and 12-months |
| Health economic analysis utilizing QoL data. | 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. | To perform health economic analyses using PRO variables. | Baseline, 3-months, and 12-months. |
| Thematic analysis of interview data. | 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. | 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. | 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. | 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 |
| Nantes |
| Rennes |
| 44093 |
| France |
| Zentralklinik Bad Berka Gmbh | Bad Berka | 99437 | Germany |
| BG-Klinikum Hamburg | Hamburg | 21033 | Germany |
| Montecatone Rehabilitation Institute, Università di Bologna | Imola | Bologna | 40026 | Italy |
| Azienda Ospedaliera- Universitaria Careggi | Florence | Florence | 50134 | Italy |
| Sunnaas Sykehus HF | Nesoddtangen | 1450 | Norway |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Unidad de Lesionados Medulares Hospital Traumatología | Barcelona | 08035 | Spain |
| Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna | Stockholm | 171 76 | Sweden |
| Gastrointestinal Physiology Unit, University College London Hospital | London | NW1 2BU | United Kingdom |
| ID | Term |
|---|---|
| D055496 | Neurogenic Bowel |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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