NCT02979808

An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Dentsply International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

Detailed description

This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy

Conditions

• Neurogenic Bowel

Interventions

Type	Name	Description
DEVICE	Navina Smart	Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-12-02
• Last updated: 2019-12-12

Locations

11 sites across 8 countries: Denmark, France, Germany, Italy, Norway, Spain, Sweden, United Kingdom