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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Wellspect HealthCare

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome: Adverse Events, Adverse Device Effects [ Time Frame: 4 weeks ]

Original Secondary Outcome: Same as current

Information By: Wellspect HealthCare

Dates:
Date Received: February 25, 2016
Date Started: February 2016
Date Completion:
Last Updated: December 9, 2016
Last Verified: December 2016