SCOPE - Single-Point Classification Observational Peristo... | NCT06614491

Studies
SCOPE - Single-Point Classification Observational Peristomal Evaluation

NCT06614491

Sponsor

ConvaTec Inc.

Status

Completed

Last Update Posted

Jan 8, 2026Actual

Enrollment

605Actual

Phase

Not provided

Conditions

Ileostomy
Colostomy
Urostomy

Interventions

Not provided

Countries

Brazil
Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2024Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Sep 24, 2024

First Submission Date that Met QC Criteria

Sep 24, 2024

First Posted Date

Sep 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

605Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ileostomy		Subjects with ileostomy
Colostomy		Subjects with colostomy
Urostomy		Subjects with urostomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability of SACS assessment	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Guerrero, MD	Principal Investigator Colombia	Principal Investigator
Maria Angela Boccara de Paula, PhD	Principal Investigator Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ConvaCare clinic		São Paulo			Brazil
ConvaCare clinic