Clinical trial NCT05652010: Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Official title: A Randomized, Controlled Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Stomas
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leakage Through Coupling Registered at Each Bag Change (Yes/no)
timeFrame: 3 weeks
Secondary outcomes:
measure: How Satisfied Are You With the New Coupling?
timeFrame: 3 weeks - evaluated at the end of the study
measure: Would You Consider Using the New Coupling in the Future?
timeFrame: Based on 3 weeks - evaluated at the end of the study period
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
Study officials:
affiliation: American Health Research
name: Selwyn Spangenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: