SCOPE - Single-Point Classification Observational Peristomal Evaluation

January 6, 2026 updated by: ConvaTec Inc.

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • ConvaCare clinic
  • Colombia
      • Bogotá, Colombia
        • ConvaCare clinic
      • Cali, Colombia
        • ConvaCare clinic
      • Medellín, Colombia
        • ConvaCare clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 600 Subjects, or 200 Subjects with ileostomy, colostomy, or urostomy peristomal skin categories

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ileostomy
Subjects with ileostomy
Colostomy
Subjects with colostomy
Urostomy
Subjects with urostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ostomy dataset
Time Frame: Baseline
Frequency of peristomal skin health classification scores in 600 consecutive ostomates
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

  • Principal Investigator: Sandra Guerrero, MD, Principal Investigator Colombia
  • Principal Investigator: Maria Angela Boccara de Paula, PhD, Principal Investigator Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OC-24-448

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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