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

NCT ID: NCT06377280

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-12-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Navina Mini

Intervention Type: DEVICE

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

Interventions

Navina Mini

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Banka Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Malmö, Sweden

Locations

Skåne University Hospital

Malmo, , Sweden

Countries

Sweden

Other Identifiers

NAV-0011

Identifier Type: -

Identifier Source: org_study_id