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Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication

NCT06739174 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-12-18

No results posted yet for this study

Summary

This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter

Conditions

  • Colostomy - Stoma
  • Colostomy Complications

Interventions

DEVICE

Confidence Be 1-Piece Closed Bag

Active Chamber Filter - Circle Shape

DEVICE

Confidence Natural 1-Piece Closed Bag

Protective Filter - Circle Shape

DEVICE

Confidence Be go 1-Piece Closed Bag

Active Chamber Filter - Hexagon Shape

Sponsors & Collaborators

  • Salts Healthcare

    lead INDUSTRY

Principal Investigators

  • Mireille Hamson · Salt Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-29
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • 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 NCT06739174 on ClinicalTrials.gov