Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation

Stoma Ileostomy Clinical Trial

Official title:

Investigation of Patient Benefits With a New Supporting Ostomy Product and Support Service in Patients With a Newly Stoma Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135754
• Other study ID #: CP340
• Status: Completed
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: August 22, 2022

Study information

• Verified date: November 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.

To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have provide written informed consent.

2. Be at least 18 years of age and have full capacity.

3. Have had their stoma for less than 9 months.

4. Have intact skin on the peristomal area (assessed by investigator)

5. Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)

6. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)

7. Is willing to refrain from use of paste and protective sheets.

8. Have a smartphone applicable for the HeyloTM app.

9. Have been self-managing stoma appliance for at least 14 days.

10. Are able to follow study procedures for 3 months (assessed by investigator)

11. Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.

Exclusion Criteria:

1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.

2. Is breastfeeding.

3. Is pregnant based on urine pregnancy test.

4. Enrolled in another current research study or have previously participated in this investigation.

5. Has known hypersensitivity towards any of the products used in the investigation.

6. Is using/have a pacemaker.

7. Has a complicated stoma at baseline (dehiscence/prolapse/hernia)

8. Has limited life expectancy or receive palliative care.

9. Has stage 4 cancer.

10. Having more than one stoma synchronously

11. Having ongoing non-healed abdominal wounds

12. Reoperation / stoma reversal planned during the study period.

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• Heylo
Test of the supporting product (test product) for a 12 weeks period. No measurement will be conducted. All endpoints are captured via surveys send to the subjects every 14 days.

Locations

Country	Name	City	State
United Kingdom	Southmead/North Bristol NHS Trust	Bristol
United Kingdom	Chelsea & Westminster Hospital	Chelsea
United Kingdom	Devon/Royal Devon and Exeter NHS Foundation Trust	Exeter
United Kingdom	Norfolk/James Paget University Hospitals NHS Foundation Trust	Great Yarmouth
United Kingdom	Leeds/Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Illingworth	Manchester
United Kingdom	Middlesbrough/South Tees NHS trust, James Cook University Hospital	Middlesbrough
United Kingdom	Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital	Peterborough
United Kingdom	Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital	Preston

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of times with stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets) within the last 2 weeks	Survey question: Subjects are ask to think 2 weeks back	Every second week
Secondary	Patient Self-management	Patient Activation Measure (PAM) score	Every second week
Secondary	Leakage related quality of life	OLI score (Ostomy Leakage Impact score	Every second week
Secondary	Health Related Quality of Life	EQ5D-5L	Every second week