Clinical trial NCT06377280: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Dysfunction
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of clinical benefit
timeFrame: 4 weeks
measure: Ease of handling
timeFrame: 4 weeks
measure: Safety Outcome
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: University Hospital of Malmö, Sweden
name: Louis Banka Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: