Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Wellspect HealthCare

Status: Completed

Conditions: Neurogenic Bowel

Treatments: Device: Navina Smart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709395

NAV-0003

Details and patient eligibility

About

This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. Males and females, aged 18 years and over
3. Practice TAI since at least 2 months and at least two times per week
4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator

Exclusion criteria

1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions
2. Untreated rectal impaction
3. Any radiotherapy to the pelvis
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel)
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
6. Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
8. Overt or planned pregnancy
9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
12. Previous enrolment in the present study
13. Participation in another clinical study within the last 30 days that may interfere with the present study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Navina Smart

Experimental group

Description:

Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).

Treatment:

Device: Navina Smart