NCT06614491

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

September 24, 2024

Last Update Submit

January 6, 2026

Conditions

IleostomyColostomyUrostomy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Ostomy dataset

    Baseline

Study Arms (3)

Ileostomy

Subjects with ileostomy

Colostomy

Subjects with colostomy

Urostomy

Subjects with urostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Enterocutaneous fistulae
  • Patients with two or more ostomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ConvaCare clinic

São Paulo, Brazil

Location

ConvaCare clinic

Bogotá, Colombia

Location

Convacare clinic

Cali, Colombia

Location

ConvaCare clinic

Medellín, Colombia

Location

Study Officials

  • Sandra Guerrero, MD

    Principal Investigator Colombia

    PRINCIPAL INVESTIGATOR

  • Maria Angela Boccara de Paula, PhD

    Principal Investigator Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

December 6, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

CO(3)BR(1)