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 2-piece coupling system with SenSura Mio Click.

Study Overview

• Status: Completed
• Conditions: Surgical Stomas
• Intervention / Treatment: Device: New 2-piece Coupling; Device: 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.

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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)
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; The arm includes the new 2-piece coupling	Device: New 2-piece Coupling; Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
Active Comparator: Comparator device; The arm includes the existing 2-piece coupling	Device: SenSura Mio Click; Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leakage Through Coupling Registered at Each Bag Change (Yes/no)	Output visible inside and/or outside the coupling system when the bag is changed. Presented in proportion of bag changes (with leakage) per participant.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How Satisfied Are You With the New Coupling?	Satisfaction with new coupling evaluated at end of study by a question on a 4-point scale (very satisfied - satisfied - dissatisfied - very dissatisfied)	3 weeks - evaluated at the end of the study
Would You Consider Using the New Coupling in the Future?	Preference evaluated at end of the investigation by the question "Would you consider using the new coupling in the future?" (Yes/No)	Based on 3 weeks - evaluated at the end of the study period

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Selwyn Spangenthal, MD, American Health Research

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

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