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

Neurogenic Bowel Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709395
• Other study ID #: NAV-0003
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2022
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bowel

Intervention

Device:
• Navina Smart
Transanal irrigation at the same frequency as subject used before enrollment.

Locations

Country	Name	City	State
Sweden	Neurologiska kliniken, Karolinska Universitetssjukhuset Solna	Stockholm
United Kingdom	Gastrointestinal Physiology Unit, University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart	Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.	4 weeks