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

NCT02709395 | Completed Results

• 1 other identifier: NAV-0003
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Neurogenic Bowel

Outcome Measures

Primary Outcomes (3)

• Questionnaire Measuring Subjects' Satisfaction of Navina Smart

  PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"

  4 weeks

• Questionnaire Measuring Subjects' Perception of Navina Smart

  PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"

  4 weeks

• Questionnaire Measuring Subjects' Compliance of Navina Smart

  PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"

  4 weeks

Secondary Outcomes (1)

• Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart

  4 weeks

Study Arms (1)

Navina Smart

EXPERIMENTAL

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

Device: Navina Smart

Interventions

Navina Smart DEVICE

Transanal irrigation at the same frequency as subject used before enrollment.

Navina Smart

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• Untreated rectal impaction
• Any radiotherapy to the pelvis
• Any current treatment with anticoagulants (not including aspirin or clopidogrel)
• Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
• Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision)
• Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
• Overt or planned pregnancy
• Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
• Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
• Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
• Previous enrolment in the present study
• Participation in another clinical study within the last 30 days that may interfere with the present study

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (2)

Neurologiska kliniken, Karolinska Universitetssjukhuset Solna

Stockholm, 171 76, Sweden

Location

Gastrointestinal Physiology Unit, University College London Hospital

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Neurogenic Bowel

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Head of Medical Affairs, Markus Wittebo
• Organization: Wellspect HealthCare

markus.wittebo@wellspect.com

+46 31 376 40 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 16, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); GB (1)