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A clinical feasibility and performance study on the use of IntelligynAI for AI-driven support in ultrasound assessment of ovarian tumours

A clinical feasibility and performance study on the use of IntelligynAI for computer-aided diagnostic support (CADs) in ultrasound assessment of ovarian tumours

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN90989270
Enrollment
60
Registered
2024-12-18
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Women with newly detected ovarian lesions, undergoing transvaginal ultrasound examination. Urological and Genital Diseases

Interventions

The study aims to asses a clinical workflow where examining physicians utilize AI-driven diagnostic support. During the ultrasound examination, selected images are sent to the IntelligynAI platform, w

Sponsors

Karolinska Institutet
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with newly detected adnexal lesions (known for less than 4 months).

Exclusion criteria

Exclusion criteria: Individuals with a mental or psychological disability limiting their ability to give informed consent. Women with adnexal lesions known for more than 4 months. Women under 18 years of age.

Design outcomes

Primary

MeasureTime frame
Self-perceived confidence in the diagnosis and management provided by the examiner, in a study protocol, at the baseline ultrasound examination, self-perceived satisfaction and workload using AI support, through a doctor´s questionnaire, at the end of the trial

Secondary

MeasureTime frame
1. Percentage of cases with adequately collected and selected images, trough the review of patients files at the end of the trial 2. Diagnostic accuracy: Alignment of the physician’s assessment with AI support, trough the study protocol filled out by the examiner at the time of the baseline ultrasound examination against final outcomes (from histology or ultrasound follow-up over at least 9 months), through the review of patient's files, at the end of the trial

Countries

Sweden

Contacts

Public ContactElisabeth Epstein
elisabeth.epstein@ki.se+46 852487570

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026