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Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

NCT05466721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-01-18

No results posted yet for this study

Summary

The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.

The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.

Conditions

  • Colostomy Stoma

Interventions

DEVICE

Hydrustoma C3

The participant will use the device for 14 days.

DEVICE

Coloplast Alterna

The participant will use the device for 14 days.

Sponsors & Collaborators

  • Hydrumedical

    lead INDUSTRY

Principal Investigators

  • Palmira Peixoto · Hospital de Braga

  • Paula Costa · Hospital Da Senhora Da Oliveira - Guimarães

  • Liliana Miranda · Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro

  • Sara Costa · Centro Hospitalar de Entre o Douro e Vouga

  • Glória Gonçalves · Centro Hospitalar de Vila Nova de Gaia/Espinho

  • Carla Nunes · Centro Hospitalar do Tâmega e Sousa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-12-19
Completion
2023-12-31

Countries

  • Portugal

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 NCT05466721 on ClinicalTrials.gov