Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma (CP343)

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

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

Study Overview

• Status: Completed
• Conditions: Stoma Site Leakage
• Intervention / Treatment: Device: Iris - new coupling; Device: Sensura Mio Click

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carri Browne; Phone Number: 16123235772; Email: dkcarr@coloplast.com

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Coupling	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
Active Comparator: Comparator Device	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coupling Leakage	Leakage through coupling registered at each bag change (yes/no).	3 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CP343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes