Back to resultsEvaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Primary Purpose
Neurogenic Bowel
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Navina Smart
Sponsored by
About this trial
This is an interventional other trial for Neurogenic Bowel
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- Males and females, aged 18 years and over
- Practice TAI since at least 2 months and at least two times per week
- Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator
Exclusion Criteria:
- 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
- Untreated rectal impaction
- Any radiotherapy to the pelvis
- Any current treatment with anticoagulants (not including aspirin or clopidogrel)
- Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
- Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
- Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
- Overt or planned pregnancy
- Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
- Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
- Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
- Previous enrolment in the present study
- Participation in another clinical study within the last 30 days that may interfere with the present study
Sites / Locations
- Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
- Gastrointestinal Physiology Unit, University College London Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Navina Smart
Arm Description
Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).
Outcomes
Primary Outcome Measures
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?"
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?"
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?"
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02709395
Brief Title
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Official Title
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellspect HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bowel
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navina Smart
Arm Type
Experimental
Arm Description
Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).
Intervention Type
Device
Intervention Name(s)
Navina Smart
Intervention Description
Transanal irrigation at the same frequency as subject used before enrollment.
Primary Outcome Measure Information:
Title
Questionnaire Measuring Subjects' Satisfaction of Navina Smart
Description
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?"
Time Frame
4 weeks
Title
Questionnaire Measuring Subjects' Perception of Navina Smart
Description
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?"
Time Frame
4 weeks
Title
Questionnaire Measuring Subjects' Compliance of Navina Smart
Description
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?"
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart
Description
Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent
Males and females, aged 18 years and over
Practice TAI since at least 2 months and at least two times per week
Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator
Exclusion Criteria:
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
Untreated rectal impaction
Any radiotherapy to the pelvis
Any current treatment with anticoagulants (not including aspirin or clopidogrel)
Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
Overt or planned pregnancy
Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
Previous enrolment in the present study
Participation in another clinical study within the last 30 days that may interfere with the present study
Facility Information:
Facility Name
Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Gastrointestinal Physiology Unit, University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
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