IleostomyNCT06614491
SCOPE - Single-Point Classification Observational Peristomal Evaluation
An observational study of Ileostomy and Colostomy, run by ConvaTec Inc. at 4 sites in 2 countries.
Trial summary
Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 605 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 600 Subjects, or 200 Subjects with ileostomy, colostomy, or urostomy peristomal skin categories
Who may be able to join
- Patients with ileostomy, colostomy or urostomy
- Age ≥ 18 years of age
- Able and willing to provide informed consent
Who cannot join
- Enterocutaneous fistulae
- Patients with two or more ostomies
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Colombia3 sites
ConvaCare clinic
Bogotá
Convacare clinic
Cali
ConvaCare clinic
Medellín
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ileostomy | Subjects with ileostomy | |
| Colostomy | Subjects with colostomy | |
| Urostomy | Subjects with urostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
Ostomy dataset
Frequency of peristomal skin health classification scores in 600 consecutive ostomates
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start6 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Guerrero, MD, Principal investigator, Principal Investigator ColombiaMaria Angela Boccara de Paula, PhD, Principal investigator, Principal Investigator Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614491
- Sponsor's protocol ID
- OC-24-448
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
- ClinicalTrials.gov ID
- NCT06614491
- Acronym / sponsor ID
- OC-24-448
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ileostomy | – | –Subjects with ileostomy |
| Colostomy | – | –Subjects with colostomy |
| Urostomy | – | –Subjects with urostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 600 Subjects, or 200 Subjects with ileostomy, colostomy, or urostomy peristomal skin categories
Key inclusion criteria (3 listed)
- Patients with ileostomy, colostomy or urostomy
- Age ≥ 18 years of age
- Able and willing to provide informed consent
Key exclusion criteria (2 listed)
- Enterocutaneous fistulae
- Patients with two or more ostomies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Ostomy dataset
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Guerrero, MD principal investigator
Principal Investigator Colombia
Maria Angela Boccara de Paula, PhD principal investigator
Principal Investigator Brazil
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileostomy and Colostomy, run by ConvaTec Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of SACS assessment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.