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OpenTrials
Completed

NCT Number: NCT06377280

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

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Key information

Conditions

Bowel Dysfunction Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital

Malmö, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navina Mini

Device

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

Primary outcomes

  1. Patient satisfaction

    Time frame: 4 weeks

    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]

Secondary outcomes

  1. Assessment of clinical benefit

    Time frame: 4 weeks

    Patient Reported Outcome on Fecal Incontinence and Defecation syndrome

  2. Ease of handling

    Time frame: 4 weeks

    Patient Reported Outcome on perception of handling the device

  3. Safety Outcome

    Time frame: 4 weeks

    Assessment of adverse events and device deficiencies

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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