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Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis

NCT04707976 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-07-11

No results posted yet for this study

Summary

A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.

Conditions

Interventions

DEVICE

Navina Smart

CE-marked NavinaTM Smart including Navina Smart App.

OTHER

Standard Bowel Care

Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Brigitte Schürch, Prof. · Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne

  • Bonaventura Casanova, Dr. · Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Denmark
  • France
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04707976 on ClinicalTrials.gov