Investigation of a Supporting Ostomy Product Intended for Leakage Detection

NCT04894084 | Completed Results

• 1 other identifier: CP321
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

People with intestinal stomas (especially an ileostomy) 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, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject. Single arm design. Open-labelled Study duration: 21 days + 3 days.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• System Performance Accuracy of Pictures

  The primary endpoint is system performance accuracy: * True Negative: No leakage observed on picture and no leakage detected by system * True Positive: Leakage observed in picture and leakage detected by system * False Negative: Leakage observed in picture, but no leakage detected by system * False Positive: No leakage observed in picture, but leakage detected by system

  21 days

Secondary Outcomes (19)

• Frequency of Leakage Onto Clothes Before and After Use of Test Product

  At V1 (baseline) and V2 (follow-up, Day 21)

• Experience of Leakage Onto Clothes Compared to Only Using Usual Product

  V2 (follow-up, Day 21)

• Reliability of Notifications

  V2 (follow-up, Day 21)

• Ability to Move With Test Product

  V2 (follow-up, Day 21)

• Subjects Worry of Leakage Before and After Use of Test Product

  At V1 (baseline) and V2 (follow-up, Day 21)

Study Arms (1)

Test product

EXPERIMENTAL

Subjects are requested to use the test device (supporting product) beneath their ostomy baseplate. Subjects may change their appliance as they wish, either they may change due to a notification from the app and/or follow their change routine.

Device: CP321

Interventions

CP321 DEVICE

The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study

Test product

Eligibility Criteria

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

You may qualify if:

• Have given written informed consent
• Be at least 18 years of age and have full legal capacity
• Have had a stoma for more than three months
• Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
• Be able to use one of the five sensor layer sizes (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
• Ileo- or colostomists with liquid output (Bristol scale type 6-7).
• Currently using a Coloplast product (1pc/2pc Flat/Convex/Concave) from e.g Assura/SenSura/SenSura Mio
• Have self-reported problems with leakage\* (three times within 14 days)
• Have worry of leakage 'to some, high or very high degree'
• Is familiar with the use of a smartphone \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

You may not qualify if:

• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• Are pregnant or breastfeeding
• Known sensitivity towards test product
• Known sensitivity towards acrylate
• Is using/have a pacemaker
• Is using ostomy paste or ostomy powder

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Related Publications (1)

• Brady RR, Fellows J, Meisner S, Olsen JK, Vestergaard M, Ajslev TA. A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life. Br J Nurs. 2023 Mar 23;32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4.

  PMID: 36952372 DERIVED

Results Point of Contact

• Title: Medical Affairs Project Manager
• Organization: Coloplast A/S

dkteaa@coloplast.com

+4549111341

Study Officials

• Søren Meisner, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• 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

Model Details: Single arm, open label study. Subjects are allocated to use test product for 3 weeks. Subjects will complete questionnaires at baseline (V1) and again after 3 weeks use of test product (V2). Comparative tests included: Baseline vs. follow-up measures.

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: April 29, 2021
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: September 22, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)