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This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navina Smart | Experimental | Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navina Smart | Device | Transanal irrigation at the same frequency as subject used before enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire Measuring Subjects' Satisfaction of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?" | 4 weeks |
| Questionnaire Measuring Subjects' Perception of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?" | 4 weeks |
| Questionnaire Measuring Subjects' Compliance of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?" | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart | Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologiska kliniken, Karolinska Universitetssjukhuset Solna | Stockholm | 171 76 | Sweden | |||
| Gastrointestinal Physiology Unit, University College London Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Navina Smart | Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Navina Smart | Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Questionnaire Measuring Subjects' Satisfaction of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?" | Intention To Treat Analysis Set | Posted | Count of Participants | Participants | 4 weeks |
|
The safety of Navina Smart, e.g. registration of Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), were collected throughout the study period for 4 weeks of each participating subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Navina Smart | Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Broke left leg | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs, Markus Wittebo | Wellspect HealthCare | +46 31 376 40 00 | markus.wittebo@wellspect.com |
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| ID | Term |
|---|---|
| D055496 | Neurogenic Bowel |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| London |
| NW1 2BU |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bowel Management at Baseline - Satisfaction | The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1. | Count of Participants | Participants |
|
| TAI therapy at Baseline | The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1. | Count of Participants | Participants |
|
| Time spent bowel management at Baseline | Measure Description: The Baseline Questionnaire is a study-specific, non-validated instrument, developed by Wellspect HealthCare. The Baseline Questionnaire is self-administered and was completed by the subjects at Visit 1. | Data missing for 4 subjects, no response received | Mean | Full Range | minutes |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Questionnaire Measuring Subjects' Perception of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?" | Intention To Treat Analysis Set | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | Questionnaire Measuring Subjects' Compliance of Navina Smart | PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?" | Intention To Treat Analysis Set | Posted | Count of Participants | Participants | 4 weeks |
|
|
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| Secondary | Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart | Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient. | Safety Analysis Set | Posted | Number | number of events | 4 weeks |
|
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|
| 0 |
| 28 |
| 3 |
| 28 |
| Vomiting | Gastrointestinal disorders |
|
| Skin infection elbow | Skin and subcutaneous tissue disorders |
|
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| D004066 | Digestive System Diseases |