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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

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE March 16, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE February 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
Adverse Events, Adverse Device Effects [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Official Title  ICMJE Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Neurogenic Bowel
Intervention  ICMJE Device: Navina Smart
Transanal irrigation at the same frequency as subject used before enrollment.
Study Arms  ICMJE Experimental: Navina Smart
Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).
Intervention: Device: Navina Smart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2016)
30
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02709395
Other Study ID Numbers  ICMJE NAV-0003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wellspect HealthCare
Study Sponsor  ICMJE Wellspect HealthCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wellspect HealthCare
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP