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

NCT06377280 | Completed

• 1 other identifier: NAV-0011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of clinical benefit

  4 weeks

• Ease of handling

  4 weeks

• Safety Outcome

  4 weeks

Study Arms (1)

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

Device: Navina Mini

Interventions

Navina Mini DEVICE

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

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Louis Banka Johnson, MD

  University Hospital of Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: April 22, 2024
• Study Start: January 18, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

SE (1)