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

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.

Study Overview

• Status: Completed
• Conditions: Bowel Dysfunction
• Intervention / Treatment: Device: Navina Mini

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects; 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	Device: Navina Mini; CE-marked Navina Mini, released on the market May 2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of clinical benefit	Patient Reported Outcome on Fecal Incontinence and Defecation syndrome	4 weeks
Ease of handling	Patient Reported Outcome on perception of handling the device	4 weeks
Safety Outcome	Assessment of adverse events and device deficiencies	4 weeks

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Louis Banka Johnson, MD, University Hospital of Malmö, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: NAV-0011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No