N/A N=25 Supportive Care

Investigation of a Supporting Ostomy Product Intended for Leakage Detection

Stoma Ileostomy

Bottom Line

View on ClinicalTrials.gov: NCT04894084 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: System Performance Accuracy of Pictures — 122; 126; 24; 45 Pictures

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CP321 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY System Performance Accuracy of Pictures	122; 126; 24; 45	—
SECONDARY Frequency of Leakage Onto Clothes Before and After Use of Test Product	2.84; 0.51	<0.001 sig
SECONDARY Experience of Leakage Onto Clothes Compared to Only Using Usual Product	0; 0; 2; 3; 18	<0.0001 sig
SECONDARY Reliability of Notifications	5; 7; 6; 3; 2	0.0106 sig
SECONDARY Ability to Move With Test Product	0; 1; 16; 4; 2	<0.0001 sig
SECONDARY Subjects Worry of Leakage Before and After Use of Test Product	1; 11; 11; 2; 0; 0	<0.001 sig
SECONDARY Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product	18; 5	0.0106 sig
SECONDARY Confidence in Daily Life Compared to Only Using Usual Product	1; 2; 5; 10; 5	0.21
SECONDARY Feeling of Control With Test Product Compared to Only Using Usual Product	18; 5	0.0106 sig
SECONDARY Control of Leakage Progression With Test Product Compared to Only Using Usual Product	16; 7	0.093
SECONDARY Feeling of Security With Test Product Compared to Only Using Usual Product	1; 22	<0.0001 sig
SECONDARY Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product	2; 21	<0.0001 sig
SECONDARY Evaluation of Sleep With Test Product Compared to Only Using Usual Product	8; 0; 15	0.21
SECONDARY Confidence at Night With Test Product Compared to Only Using Usual Product	0; 1; 11; 7; 4	1.00
SECONDARY Evaluation of Users' Preference	10; 13	0.678
SECONDARY Reason for Preference	2; 1; 10; 2; 9; 2	—
SECONDARY Evaluation of Users' Peace of Mind With Test Product	6; 10; 5; 2	0.0931
SECONDARY To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product	3; 20	0.0005 sig
SECONDARY Adhesive Residue to Skin	6; 7; 7; 2; 1	—
SECONDARY Adhesive Residue to Transmitter	9; 5; 9; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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
Participating in other interventional clinical investigations or have previously participated in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol.
Known sensitivity towards test product
Known sensitivity towards acrylate
Is using/have a pacemaker
Is using ostomy paste or ostomy powder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04894084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.