Post Market Clinical Follow-up Study Evaluating Performance & Safety of

Status Withdrawn

Clinical Trial Summary

This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device. The device is comprised by a baseplate connected to a bag. The coupling between baseplate and bag can be either welded together, referred to as a 1-piece (1P) system, or assembled as separate parts, referred to as a 2-piece (2P) system.

Clinical Trial Description

The purpose of this research is to gather more information about how well the SenSura® Mio Kids ostomy device works, and how safe it is. This device has already been studied and approved to be used in the United States. It has a European CE-mark, which means it has met European health and safety requirements. SenSura® Mio Kids is a flat ostomy device that is made to be used for kids from 6 months up to 4 years of age. The reason for this study is to find out how well the new SenSura® Mio Kids device works compared to the standard of care device. We can learn about this by asking people who have used it about how well it worked and how comfortable it was. The Investigator/study nurse will decide whether the subject would benefit from switching to SenSura® Mio Kids and if so, the subject will be invited to take part in the study. The study design is observational. That means that the ostomy device, and the skin around the stoma, will be observed while receiving the stoma care they normally would. This study design will help the researchers see how well the device works when it is used in the usual way, and makes it easier for the people who are participating in the study. ;

Study Design

Related Conditions & MeSH terms

Stoma Ileostomy

Clinical Trial Details

NCT number	NCT03784989
Study type	Observational
Source	Coloplast A/S
Contact
Status	Withdrawn
Phase
Start date	April 15, 2019
Completion date	September 8, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06269276` - Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
Not yet recruiting	`NCT05076669` - Quality of Life Impact After Enhanced Follow-up of Ostomy Patients	N/A
Terminated	`NCT03016195` - Evaluation of the Normal Range of Urinary Sodium Levels in Healthy Newborn Babies	N/A
Recruiting	`NCT04763863` - The Nordic Consensus Study
Completed	`NCT05970458` - Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden
Completed	`NCT05601024` - The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma	N/A
Completed	`NCT05135754` - Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation	N/A
Completed	`NCT01994902` - Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy	N/A
Recruiting	`NCT03424447` - Stimulation of the Efferent Loop Before Loop Ileostomy Closure	Phase 2
Recruiting	`NCT04984161` - The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses	N/A
Completed	`NCT05531331` - The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma	N/A
Active, not recruiting	`NCT06458699` - Management Of Stoma In Patients Younger Than 3 Months Old
Recruiting	`NCT04374890` - Evaluation of a New Supporting Ostomy Product	N/A
Not yet recruiting	`NCT06391398` - The Impact of Education Using a Stoma Care Training Belt	N/A
Recruiting	`NCT04709445` - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses	N/A
Completed	`NCT04744792` - QoL of Colorectal Cancer Patients and Spouses
Completed	`NCT03971513` - Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study	N/A
Completed	`NCT03200444` - Evaluation of the Peel Force of New Adhesives From the Skin	N/A
Completed	`NCT03619226` - Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture	N/A
Completed	`NCT06237686` - Clinical Investigation Exploring Two Ostomy Product Prototypes	N/A

Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms