Trials / Completed
CompletedNCT02709395
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Wellspect HealthCare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Navina Smart | Transanal irrigation at the same frequency as subject used before enrollment. |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2016-03-16
- Last updated
- 2023-01-26
- Results posted
- 2023-01-26
Locations
2 sites across 2 countries: Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02709395. Inclusion in this directory is not an endorsement.