En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.

Bowel Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06377280
• Other study ID #: NAV-0011
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Wellspect HealthCare
• Contact: Louis Banka Johnson
• Phone: +4640336557
• Email: louis_banka.johnson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases

Intervention

Device:
• Navina Mini
CE-marked Navina Mini, released on the market May 2023

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	4 weeks
Secondary	Assessment of clinical benefit	Patient Reported Outcome on Fecal Incontinence and Defecation syndrome	4 weeks
Secondary	Ease of handling	Patient Reported Outcome on perception of handling the device	4 weeks
Secondary	Safety Outcome	Assessment of adverse events and device deficiencies	4 weeks