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Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

NCT05032534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-08-09

No results posted yet for this study

Summary

The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.

Conditions

  • Fecal Incontinence
  • Constipation - Functional

Interventions

DEVICE

Cone Small, Qufora A/S

Newly developed cone in a softer material and a design matching the use for transanal irrigation.

DEVICE

Colotip, Coloplast A/S

Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Qufora A/S

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Denmark

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 NCT05032534 on ClinicalTrials.gov