NCT05652010

Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.

Detailed description

It will be a 1:1 randomization into the two possible treatment sequences Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days). All visits will be performed as remote virtual calls. At the visits, the investigator will give instructions for the coming period and check that the trial is running as planned. At every bag change the subject will be asked to complete a questionnaire. A follow-up call will be scheduled 7±1 days after each test visit to ensure compliance with the provided product and study procedures. Additional calls may be scheduled if needed. Minimum 40 participants will be enrolled and randomized.

Conditions

• Surgical Stomas

Interventions

Type	Name	Description
DEVICE	New 2-piece Coupling	Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
DEVICE	SenSura Mio Click	Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2022-12-15
• Last updated: 2025-02-19
• Results posted: 2024-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study