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

Neurogenic Bowel Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02979808
Study type Interventional
Source Dentsply International
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date December 2019
View Details
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