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

NCT02979808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-12-12

No results posted yet for this study

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.

Conditions

  • Neurogenic Bowel

Interventions

DEVICE

Navina Smart

Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Sponsors & Collaborators

  • Wellspect HealthCare

    collaborator INDUSTRY

  • Dentsply International

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Denmark
  • France
  • Germany
  • Italy
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979808 on ClinicalTrials.gov