NCT05466721

Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

HydrustomaC3 - Randomized Clinical Trial to Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hydrumedical · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Hydrustoma C3	The participant will use the device for 14 days.
DEVICE	Coloplast Alterna	The participant will use the device for 14 days.

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-12-19
• Completion: 2023-12-31
• First posted: 2022-07-20
• Last updated: 2024-01-18

Locations

6 sites across 1 country: Portugal