Diagnosis of axillary lymph node status in primary breast cancer without a surgical procedure - a human factors validation test

Human factors validation study of an artificial neural network-based preoperative decision-support tool for noninvasive lymph node staging (NILS) in women with primary breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN99301435

Enrollment

Registered

2024-11-15

Start date

2024-09-12

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-market human factor validation test with intended (actual) users. Cancer

Interventions

The test participants will be greeted by the test leader and be provided a written instruction for use manual. The test participants will be presented with five simulated cases and are expected to fil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Intended users - licensed medical physicians specialized in general surgery or oncology (including medical and radiation oncologists) 2. >18 years 3. Both sexes

Exclusion criteria

Exclusion criteria: 1. Any former contact with the device

Design outcomes

Primary

Measure	Time frame
1. Frequency of observed outcome and result during the test, analysis per task. Observed outcome is defined as correct use, close call, use difficulty, and use error. Result is defined as passed or failed. 2.Frequency of passed critical tasks per scenario. 3.Frequency of observed outcome and result during the test, analysis per task description in association with potential harm (false estimated indication of benign sentinel lymph node). Observed outcome is defined as correct use, close call, use difficulty, and use error. Result is defined as passed or failed. 4.Average point (median) on Likert scale 1-5 and 1-7: 1 “strongly disagree” to 5 respectively 7 “strongly agree” in validated questionnaire (Lewis J.R 2018 and 1995). 5.Review of all comments in validated questionnaire (Lewis J.R 2018 and 1995) and interview data with the purpose to detect potential safety and performance concerns. Since NILS has not yet been released to the market and has had limited contact with the intended users, it is likely that some usability issues may be detected. However, a large amount of user errors is not acceptable. Therefore, the team has set the acceptance criteria to 90%. Each test protocol interview data will be reviewed and all comments with potential safety and performance concerns will be analyzed to assess any required changes in design. In case any significant change of the NILS web page will be needed, the change will be re-assessed using a new scenario with the purpose to re-evaluate the potential concern. The qualitative evaluation will be acceptable when no potential safety and performance concerns remain to be analyzed or addressed.	—

Measure

Time frame

1. Frequency of observed outcome and result during the test, analysis per task. Observed outcome is defined as correct use, close call, use difficulty, and use error. Result is defined as passed or failed. 2.Frequency of passed critical tasks per scenario. 3.Frequency of observed outcome and result during the test, analysis per task description in association with potential harm (false estimated indication of benign sentinel lymph node). Observed outcome is defined as correct use, close call, use difficulty, and use error. Result is defined as passed or failed. 4.Average point (median) on Likert scale 1-5 and 1-7: 1 “strongly disagree” to 5 respectively 7 “strongly agree” in validated questionnaire (Lewis J.R 2018 and 1995). 5.Review of all comments in validated questionnaire (Lewis J.R 2018 and 1995) and interview data with the purpose to detect potential safety and performance concerns. Since NILS has not yet been released to the market and has had limited contact with the intended users, it is likely that some usability issues may be detected. However, a large amount of user errors is not acceptable. Therefore, the team has set the acceptance criteria to 90%. Each test protocol interview data will be reviewed and all comments with potential safety and performance concerns will be analyzed to assess any required changes in design. In case any significant change of the NILS web page will be needed, the change will be re-assessed using a new scenario with the purpose to re-evaluate the potential concern. The qualitative evaluation will be acceptable when no potential safety and performance concerns remain to be analyzed or addressed.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Sweden

Contacts

Public ContactAnna Allfelt

anna.allfelt@med.lu.se+46 (0)40335357

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026