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

NCT05652010 | Completed Results FDA Device

• 1 other identifier: CP343
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Stomas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• How Satisfied Are You With the New Coupling?

  3 weeks - evaluated at the end of the study

• Would You Consider Using the New Coupling in the Future?

  Based on 3 weeks - evaluated at the end of the study period

Study Arms (2)

New coupling

EXPERIMENTAL

The arm includes the new 2-piece coupling

Device: New 2-piece Coupling

Comparator device

ACTIVE COMPARATOR

The arm includes the existing 2-piece coupling

Device: SenSura Mio Click

Interventions

New 2-piece Coupling DEVICE

Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.

New coupling

SenSura Mio Click DEVICE

Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.

Comparator device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given written consent to participate by signing the Informed Consent Signature Form
• Be at least 18 years of age and have full legal capacity
• Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves
• Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale)
• Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size
• Have had their ostomy for at least 90 days
• Be willing to change the bag at least twice per week
• Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation
• Is willing to use 2p maxi open bags during the investigation

You may not qualify if:

• 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.
• 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.
• Is pregnant and/or breast-feeding
• Have a loop ileostomy
• Is currently using convex baseplate
• Has known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

American Health Research

Charlotte, North Carolina, 28277, United States

Location

Limitations and Caveats

The investigation was non-blinded. However, the two products came from the same manufacturer and were very similar in appearance. Subjects were instructed to register leakage through the coupling seen from the outside before opening the coupling. However, the accompanying instructive drawings showed leakage in an opened coupling, which could have resulted in overreporting of leakages that would only be visible after opening or happening when opening the coupling.

Results Point of Contact

• Title: Senior Scientific Manager
• Organization: Coloplast A/S

dkmbs@coloplast.com

+4549113192

Study Officials

• Selwyn Spangenthal, MD

  American Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: February 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: February 19, 2025
• Results First Posted: November 26, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)