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SCOPE - Single-Point Classification Observational Peristomal Evaluation

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Convatec

Status

Completed

Conditions

Colostomy
Urostomy
Ileostomy

Study type

Observational

Funder types

Industry

Identifiers

NCT06614491
OC-24-448

Details and patient eligibility

About

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

Full 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.

Enrollment

605 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

605 participants in 3 patient groups

Ileostomy
Description:
Subjects with ileostomy
Colostomy
Description:
Subjects with colostomy
Urostomy
Description:
Subjects with urostomy

Trial contacts and locations

4

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Central trial contact

Janet Kandrevas, MD; Jan Ljungqvist

Data sourced from clinicaltrials.gov

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