SCOPE - Single-Point Classification Observational Peristomal Evaluation

Not yet recruiting

• Conditions: Ileostomy; Colostomy; Urostomy

• Registration Number: NCT06614491
• Lead Sponsor: ConvaTec Inc.

Brief Summary

Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.

Detailed Description

The purpose of this study is to create an ostomy dataset and collect stoma photos to enable SACS 2.0 evaluation of images digitally versus an in-person ostomy skin assessment.

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Status Verified: 2024-11
• Study Start: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-11
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients with ileostomy, colostomy or urostomy
• Age ≥ 18 years of age
• Able and willing to provide informed consent

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Exclusion Criteria

• Enterocutaneous fistulae
• Patients with two or more ostomies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability of SACS assessment	Baseline	The equivalence of weighted Kappa concordance between SACS assessment via in-person skin assessment by an ostomy care nurse and SACS assessment via examining the skin via photo by a study nurse coordinator

Secondary Outcome Measures

Name	Time	Method
Ostomy dataset	Baseline	Frequency of peristomal skin health classification scores in 600 consecutive ostomates

Trial Locations

Locations (1)

ConvaCare clinic; 🇨🇴 Medellín, Colombia