Feasibility of a Newly Developed Ostomy Prototype

ConditionStoma - Ileostomy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorColoplast A/S

About this trial

Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

CP369 Feasibility of a newly developed ostomy prototype (only one intervention)
Device
The study is an open-label, single-arm, comparative study, investigating the feasibility of the prototype in subjects with ileostomy. The study is comparing the prototype exposed only to sweat (abdominal side) with the prototype exposed to sweat and output (peristomal side). Meaning, subjects are their own control.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Investigation (one armed study)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

To test the system performance of the prototype.

Time frame

3 weeks from enrollment to end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coloplast A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: