Surgical StomasCP343NCT05652010

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

A study testing New 2-piece Coupling and SenSura Mio Click in people with Surgical Stomas, run by Coloplast A/S at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Stomas
What is being tested?: New 2-piece Coupling and SenSura Mio Click
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 15 Feb 2023to 15 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 9Show fewer

Have a loop ileostomy
Is currently using convex baseplate
Has known hypersensitivity towards any of the products used in the investigation

Trial locations and contacts

1 site in 1 country.

United States1 site

American Health Research
Charlotte, North Carolina, 28277

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: New 2-piece Coupling, SenSura Mio Click

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New 2-piece CouplingDevice
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.
SenSura Mio ClickDevice
Flat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.

Study groups in NCT05652010
Study group	Role	What they receive
New coupling	Experimental	The arm includes the new 2-piece coupling Receives: Device: New 2-piece Coupling
Comparator device	Active comparator	The arm includes the existing 2-piece coupling Receives: Device: SenSura Mio Click

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 weeks

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202315 Jul 2023

First posted15 Dec 2022
Study start15 Feb 2023
Primary completion15 Jul 2023
Study completion15 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Surgical StomasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05652010
Sponsor's protocol ID: CP343
Acronym: CP343
Status last verified: Feb 2025
First submitted: 7 Dec 2022
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery
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All Surgical Stomas trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
ClinicalTrials.gov ID: NCT05652010
Acronym / sponsor ID: CP343 / CP343
Conditions: Surgical Stomas
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: 15 Feb 2023 (actual)
Primary completion: 15 Jul 2023 (actual)
Study completion: 15 Jul 2023 (actual)
First posted: 15 Dec 2022 (actual)
Results: Posted 26 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
New coupling	Experimental	Device: New 2-piece CouplingThe arm includes the new 2-piece coupling
Comparator device	Active comparator	Device: SenSura Mio ClickThe arm includes the existing 2-piece coupling

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (9 listed)

Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray
Is pregnant and/or breast-feeding
Have a loop ileostomy
Is currently using convex baseplate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
New 2-piece CouplingFlat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with new 50mm Ø coupling.	Device	New coupling
SenSura Mio ClickFlat or concave baseplate. SenSura Mio Click maxi bag (open, wide outlet) with 50mm Ø coupling.	Device	Comparator device

Primary outcome

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

2 secondary outcomes

How Satisfied Are You With the New Coupling?
Time frame: 3 weeks - evaluated at the end of the study
Would You Consider Using the New Coupling in the Future?
Time frame: Based on 3 weeks - evaluated at the end of the study period

Results and safety

Results posted to the registry on 26 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Coupling First, Then Comparator Device	22	22
Comparator Device First, Then New Coupling	25	24

Primary outcome: Leakage Through Coupling Registered at Each Bag Change (Yes/no)

Time frame: 3 weeks. Mean (95% Confidence Interval). Unit: Proportion of bag changes/participant

Measure	New Coupling n = 45	Comparator Device n = 46
Value	0.151 (0.089 to 0.247)	0.237 (0.156 to 0.341)

New Coupling vs Comparator Device: Odds Ratio (OR): 0.576 (95% CI 0.2634 to 1.2659), p = 0.164, Mixed Models Analysis

Population analysed: ITT

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the study period of 6 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Coupling	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Comparator Device	0 of 47 (0%)	1 of 47 (2.1%)	0 of 47

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Surgical Stomas

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Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
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Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Selwyn Spangenthal, MD principal investigator

American Health Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New 2-piece Coupling and SenSura Mio Click in people with Surgical Stomas, run by Coloplast A/S at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leakage Through Coupling Registered at Each Bag Change (Yes/no) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.