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

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ClinicalTrials.gov Identifier: NCT02709395
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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.




Primary Outcome Measures :
  1. Questionnaire measuring satisfaction in use of Navina Smart [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709395


Locations
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Sweden
Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
United Kingdom
Gastrointestinal Physiology Unit, University College London Hospital
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Wellspect HealthCare
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Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT02709395    
Other Study ID Numbers: NAV-0003
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neurogenic Bowel
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases