NCT05135754

Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.

Conditions

• Stoma Ileostomy
• Stoma Colostomy

Interventions

Type	Name	Description
DEVICE	Heylo	Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.

Timeline

• Start date: 2021-11-25
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2021-11-26
• Last updated: 2024-08-21
• Results posted: 2024-08-21

Locations

10 sites across 1 country: United Kingdom