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

Stoma Site Leakage Clinical Trial

— CP343  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05652010
• Other study ID #: CP343
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 21, 2023

Study information

• Verified date: December 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2p coupling system with SenSura Mio Click. Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days). It will be a 1:1 randomization into the two possible treatment sequences.

The investigation will require 50 randomized subjects (exp. 20% drop-out), leading to at least 40 completed subjects. The sample size calculation is based on at least 6 bag changes during each test period (≥2 chang-es per week).

All visits will be performed as remote virtual calls. At the visits, the investigator (or designee) will give in-structions for the coming period and check that the trial is running as planned. At every bag change the sub-ject will be asked to complete a questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 21, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has given written consent to participate by signing the Informed Consent Signature Form

2. Be at least 18 years of age and have full legal capacity

3. Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves

4. Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale*)

*See appendix 1

5. Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size

6. Have had their ostomy for at least 90 days

7. Be willing to change the bag at least twice per week

8. Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation

9. Is willing to use 2p maxi open bags during the investigation

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy

• low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.

2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray

• Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.

• Other systemic steroid treatment (e.g., injection or tablet) are not allowed.

3. Is pregnant and/or breast-feeding

4. Have a loop ileostomy

5. Is currently using convex baseplate

6. Has known hypersensitivity towards any of the products used in the investigation

Related Conditions & MeSH terms

• Stoma Site Leakage

Intervention

Device:
• Iris - new coupling
SenSura Mio Click maxi bag (open, wide outlet), 50mm Ø with new coupling and lock ring Baseplate flat: SenSura Mio, click base plate with belt ears, 50 mm, 10-45 mm with improved weld-ing bead Baseplate Concave: Item 18510 SenSura Mio Concave, click base plate with ears size Ø50, 10-45 mm
• Sensura Mio Click
SenSura Mio Click 2p bag, item #11472. Open, wide outlet, maxi, neutral grey. 50mm with inspection window and circle filter 430 Baseplate flat: Item #10512 SenSura Mio Click Base Plate with belt ears, 50 mm, 10-45 mm Baseplate concave: Item #18510 SenSura Mio Concave, click base plate with ears size Ø50, 10-45 mm

Locations

Country	Name	City	State
United States	American Health Research	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coupling Leakage	Leakage through coupling registered at each bag change (yes/no).	3 weeks