Bowel DysfunctionNCT06377280
En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
A study testing Navina Mini in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Sweden.
Trial summary
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- Navina Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jan 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Anal incontinence or faecal outlet problems without any pathological obstruction in the ano-rectum.
- Symptom duration of > 6 months
- Adult male and females >18 years old
- Patient can communicate in written and oral Swedish language
Who cannot join
- Subjects treated with high volume TAI i.e., volume > 250 ml
- Pregnancy at the time of enrollment
- Participating in another clinical investigation interfering with this investigation
- Subjects with active, symptomatic inflammatory bowel disease, radiation proctitis and or active perianal fistula disease
- Rectal bleeding of uncertain origin or active hemorrhoidal bleeding
- < 6 months after anal or colorectal surgery
Show all 13Show fewer
- Ongoing anti-coagulant therapy (eg. NOACS, heparin, Warfarin)
- Acute diverticulitis and diverticular abscess
- Ischemic colitis
- Colorectal cancer
- Any physical handicap that prevents usage of product
- Inability to use product or anyone to assist in its usage
- Person not suitable for the investigation according to the investigator judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Un-controlled, Prospective, Multi-center, Post Market Clinical Follow-up Investigation to Confirm Performance and Safety of Navina Mini, a New CE-marked Low-volume Transanal Irrigation (TAI) Device.
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
- Conditions
- Bowel Dysfunction
- Being tested
- Navina Mini
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina MiniDevice
CE-marked Navina Mini, released on the market May 2023
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | The investigational subjects are persons with anal incontinence or outlet problems and deemed suitable for and in need of low-volume TAI as assessed by the investigator or designee Receives: Device: Navina Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient Reported Outcome - Overall patient satisfaction when performing low- volume trans-anal irrigation measured with a 5-graded scale [0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied]
Measured: 4 weeks
Secondary outcomes (3)
Assessment of clinical benefit
Patient Reported Outcome on Fecal Incontinence and Defecation syndrome
Measured: 4 weeks
Ease of handling
Patient Reported Outcome on perception of handling the device
Measured: 4 weeks
Safety Outcome
Assessment of adverse events and device deficiencies
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 posted22 Apr 2024
- Study start18 Jan 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DysfunctionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Banka Johnson, MD, Principal investigator, University Hospital of Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377280
- Sponsor's protocol ID
- NAV-0011
- Status last verified
- Jan 2025
- First submitted
- 28 Sep 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Un-controlled, Prospective, Multi-center, Post Market Clinical Follow-up Investigation to Confirm Performance and Safety of Navina Mini, a New CE-marked Low-volume Transanal Irrigation (TAI) Device.
- ClinicalTrials.gov ID
- NCT06377280
- Acronym / sponsor ID
- NAV-0011
- Conditions
- Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Navina MiniThe investigational subjects are persons with anal incontinence or outlet problems and deemed suitable for and in need of low-volume TAI as assessed by the investigator or designee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Anal incontinence or faecal outlet problems without any pathological obstruction in the ano-rectum.
- Symptom duration of > 6 months
- Adult male and females >18 years old
- Patient can communicate in written and oral Swedish language
Key exclusion criteria (13 listed)
- Subjects treated with high volume TAI i.e., volume > 250 ml
- Pregnancy at the time of enrollment
- Participating in another clinical investigation interfering with this investigation
- Subjects with active, symptomatic inflammatory bowel disease, radiation proctitis and or active perianal fistula disease
- Rectal bleeding of uncertain origin or active hemorrhoidal bleeding
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 MiniCE-marked Navina Mini, released on the market May 2023 | Device | All subjects |
Primary outcome
Patient satisfaction
Time frame: 4 weeks
Patient Reported Outcome - Overall patient satisfaction when performing low- volume trans-anal irrigation measured with a 5-graded scale [0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied]
3 secondary outcomes
Assessment of clinical benefit
Time frame: 4 weeks
Ease of handling
Time frame: 4 weeks
Safety Outcome
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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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.
Louis Banka Johnson, MD principal investigator
University Hospital of Malmö, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina Mini in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Sweden.
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 5 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient satisfaction (time frame: 4 weeks). 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 31 Jan 2025.