Neurogenic BowelNCT02709395
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
A study testing Navina Smart in people with Neurogenic Bowel, run by Wellspect HealthCare at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bowel
- What is being tested?
- Navina Smart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
United Kingdom1 site
Gastrointestinal Physiology Unit, University College London Hospital
London, NW1 2BU
About this study
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.
- Conditions
- Neurogenic Bowel
- Being tested
- Navina Smart
- Medical subject headings
- Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina SmartDevice
Transanal irrigation at the same frequency as subject used before enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Navina Smart | Experimental | Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Receives: Device: Navina Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 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?"
Measured: 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?"
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurogenic BowelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709395
- Sponsor's protocol ID
- NAV-0003
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2016
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
- ClinicalTrials.gov ID
- NCT02709395
- Acronym / sponsor ID
- NAV-0003
- Conditions
- Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navina Smart | Experimental | Device: Navina SmartNavina Smart will be used, during 4 weeks, for transanal irrigation (TAI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navina SmartTransanal irrigation at the same frequency as subject used before enrollment. | Device | Navina Smart |
Primary outcome
Questionnaire Measuring Subjects' Satisfaction of Navina Smart
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
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?"
1 secondary outcome
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina Smart in people with Neurogenic Bowel, run by Wellspect HealthCare at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Measuring Subjects' Satisfaction of Navina Smart (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.