SCOPE - Single-Point Classification Observational Peristomal Evaluation

NCT ID: NCT06614491

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

605 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-06

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Ileostomy Colostomy Urostomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ileostomy

Subjects with ileostomy

No interventions assigned to this group

Colostomy

Subjects with colostomy

No interventions assigned to this group

Urostomy

Subjects with urostomy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ConvaTec Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Guerrero, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator Colombia

Maria Angela Boccara de Paula, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator Brazil

Locations

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ConvaCare clinic

São Paulo, , Brazil

Site Status

ConvaCare clinic

Bogotá, , Colombia

Site Status

Convacare clinic

Cali, , Colombia

Site Status

ConvaCare clinic

Medellín, , Colombia

Site Status

Countries

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Brazil Colombia

Other Identifiers

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OC-24-448

Identifier Type: -

Identifier Source: org_study_id

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