Clinical Trials Logo

Clinical Trial 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. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.


Clinical Trial Description

The Investigational device - Heylo, is already CE-marked. The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care. In total 144 subjects having an ileostomy or an colostomy will be included and randomized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05200416
Study type Interventional
Source Coloplast A/S
Contact marie louise O. mohr
Phone +4549113506
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 2022
Completion date October 31, 2022

See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Completed NCT03331783 - Assessment of the Effect of Output on New Adhesives N/A
Completed NCT02920294 - Modulation of Microbial Composition in Ileostomy Patients N/A
Completed NCT02886455 - Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives N/A
Completed NCT02517541 - A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products N/A
Completed NCT01957553 - Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece N/A
Completed NCT01939600 - Digestibility of Selected Resistant Starches in Humans N/A
Terminated NCT01994863 - Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy Phase 2
Completed NCT01994876 - Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy N/A
Completed NCT03289013 - Assessement of the Peal Force Needed to Peel New Adhesives From the Skin N/A
Not yet recruiting NCT03872271 - Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial N/A
Completed NCT02997267 - Early Closure of Protective Ileostomy in Rectal Cancer Patients N/A
Recruiting NCT01880918 - A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing N/A
Completed NCT01957397 - Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy N/A
Terminated NCT03587519 - Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery N/A
Completed NCT04606004 - Perianal Maceration in Pediatric Ostomy Closure Patients N/A
Completed NCT02886403 - Evaluation of the Influence of Output on a Newly Develop Adhesive N/A
Recruiting NCT03424447 - Stimulation of the Efferent Loop Before Loop Ileostomy Closure Phase 2
Completed NCT03770078 - Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma N/A
Not yet recruiting NCT03953170 - Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications Phase 3