SCOPE - Single-Point Classification Observational Peristomal Evaluation

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

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Key information

Conditions

Ileostomy Colostomy Urostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ConvaCare clinic, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Enterocutaneous fistulae
Patients with two or more ostomies

Treatment and study plan

Primary outcomes

Reliability of SACS assessment

Time frame: 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 outcomes

Ostomy dataset

Time frame: Baseline

Frequency of peristomal skin health classification scores in 600 consecutive ostomates

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 26, 2024
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed