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

NCT05135754 | Completed Results

• 1 other identifier: CP340
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Stoma Ileostomy; Stoma Colostomy

Outcome Measures

Primary Outcomes (1)

• Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks

  Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?

  Baseline (Day 0) and Final Evaluation (Week 12)

Secondary Outcomes (6)

• Patient Self-management

  Baseline (Day 0) and Final Evaluation (Week 12)

• Ostomy Leakage Impact Tool - 'Emotional Impact' Domain

  Baseline (Day 0) and Final Evaluation (Week 12)

• Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain

  Baseline (Day 0) and Final Evaluation (Week 12)

• Ostomy Leakage Impact Tool - 'Coping and in Control' Domain

  Baseline (Day 0) and Final Evaluation (Week 12)

• Health Related Quality of Life

  Baseline (Day 0) and Final Evaluation (Week 12)

Study Arms (1)

Test product - new supporting ostomy product and support service

OTHER

The arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service

Device: Heylo

Interventions

Heylo DEVICE

Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.

Test product - new supporting ostomy product and support service

Eligibility Criteria

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

You may qualify if:

• Have provide written informed consent.
• Be at least 18 years of age and have full capacity.
• Have had their stoma for less than 9 months.
• Have intact skin on the peristomal area (assessed by investigator)
• Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
• Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
• Is willing to refrain from use of paste and protective sheets.
• Have a smartphone applicable for the HeyloTM app.
• Have been self-managing stoma appliance for at least 14 days.
• Are able to follow study procedures for 3 months (assessed by investigator)
• Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.

You may not qualify if:

• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Is breastfeeding.
• Is pregnant based on urine pregnancy test.
• Enrolled in another current research study or have previously participated in this investigation.
• Has known hypersensitivity towards any of the products used in the investigation.
• Is using/have a pacemaker.
• Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
• Has limited life expectancy or receive palliative care.
• Has stage 4 cancer.
• Having more than one stoma synchronously
• Having ongoing non-healed abdominal wounds
• Reoperation / stoma reversal planned during the study period.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (10)

Southmead/North Bristol NHS Trust

Bristol, United Kingdom

Location

Chelsea & Westminster Hospital

Chelsea, United Kingdom

Location

Devon/Royal Devon and Exeter NHS Foundation Trust

Exeter, United Kingdom

Location

Norfolk/James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, United Kingdom

Location

Leeds/Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Illingworth

Manchester, United Kingdom

Location

Middlesbrough/South Tees NHS trust, James Cook University Hospital

Middlesbrough, United Kingdom

Location

Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE3 3HD, United Kingdom

Location

Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital

Peterborough, United Kingdom

Location

Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital

Preston, United Kingdom

Location

Related Publications (2)

• Brady RR, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial. Br J Nurs. 2025 Jan 13;34(1):14-22. doi: 10.12968/bjon.2025.0278.

  PMID: 39792106 DERIVED

• Brady RRW, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial. J Clin Med. 2024 Sep 24;13(19):5673. doi: 10.3390/jcm13195673.

  PMID: 39407731 DERIVED

Results Point of Contact

• Title: Senior Clinical Strategy Project Manager
• Organization: Coloplast A/S

dkteaa@coloplast.com

+4549111341

Study Officials

• Richard Brady

  Newcastle-upon-Tyne Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 26, 2021
• Study Start: November 25, 2021
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)