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

• Sponsor: Wellspect HealthCare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02709395
• Collaborator: (none)
• Enrollment: 31
• Locations: 2
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bowel	Device: Navina Smart	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Navina Smart Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).	Device: Navina Smart; Transanal irrigation at the same frequency as subject used before enrollment.

Outcome Measures

Primary Outcome Measures

1. Questionnaire measuring satisfaction in use of Navina Smart [4 weeks]

   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.

2. Questionnaire measuring user friendliness of Navina Smart. [4 weeks]

   PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of user friendliness using the study device.

3. Questionnaire measuring compliance to treatment with Navina Smart. [4 weeks]

   PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on number of treatment episodes with study device.

Secondary Outcome Measures

1. Adverse Events, Adverse Device Effects [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurologiska kliniken, Karolinska Universitetssjukhuset Solna	Stockholm		Sweden	171 76
2	Gastrointestinal Physiology Unit, University College London Hospital	London		United Kingdom	NW1 2BU

Sponsors and Collaborators

• Wellspect HealthCare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wellspect HealthCare
• ClinicalTrials.gov Identifier: NCT02709395
• Other Study ID Numbers: NAV-0003
• First Posted: Mar 16, 2016
• Last Update Posted: Dec 12, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neurogenic Bowel

Study Results

No Results Posted as of Dec 12, 2016