Regulatory Watch: Not Yet Recruiting Preoperative Risk Prediction Model for Older Adults Undergoing Major Noncardiac Surgery

Meta description: This regulatory update summarizes a not yet recruiting risk prediction model for older adults undergoing major noncardiac surgery and its implications for preoperative assessment.

Publication date context: 2026-02-15. A new study record on ClinicalTrials.gov outlines a risk prediction model intended to support preoperative assessment for older adults undergoing major noncardiac surgery. The sponsor listed is Seoul National University Hospital. The trial status shows Not yet recruiting, with the intervention described as preoperative assessment. The conditions of interest include major noncardiac surgery, geriatric anesthesia and postoperative complications. This article summarizes publicly available details and highlights regulatory minded considerations as the project progresses.

What changed in risk prediction for older adults undergoing major noncardiac surgery?

The record signals a shift toward using a structured risk prediction approach to inform preoperative planning for elderly patients facing major noncardiac procedures. The intervention is described as preoperative assessment and targets postoperative complications as a key outcome area. The sponsor Seoul National University Hospital is listed, and the status Not yet recruiting indicates early stage work with data generation and model development expected before any clinical use. This section frames the topic as a regulatory aware practitioner story about how such tools may move from concept to potential regulated use.

Intended purpose and regulatory framing

The available entry states the intervention as preoperative assessment for older adults undergoing major noncardiac surgery. While no performance data are reported in the record, regulatory minded teams would view a risk prediction model as a potential decision support tool that could influence perioperative care. If the tool is pursued as a medical device then its intended use, performance claims and safety profile must be defined and supported with evidence in a regulatory submission. The description here does not imply regulatory clearance but outlines a pathway that would require formal validation and oversight.

Who is affected by this risk prediction approach?

Clinicians and institutions managing older patients heading to major noncardiac surgery are the primary audience. Geriatric anesthesia teams and perioperative medicine services would use a risk tool to inform conversations about plans for anesthesia type, monitoring needs and postoperative resource allocation. The existence of a sponsor from a major hospital signals institutional capacity to collect data and evaluate model performance. Quality and regulatory affairs professionals may monitor ongoing work to determine if and when a regulated product path is pursued.

What is known about the model and its potential role?

Model scope and input considerations

At this stage the project is described only as a risk prediction model intended to support preoperative assessment. The description does not provide technical specifications or performance metrics. Practitioners should watch for forthcoming publications or registry data that demonstrate discrimination calibration and usability. If later marketed as a device the model would require clear integration details to support decision making without compromising patient safety.

What evidence and regulatory considerations apply?

Because the trial status is Not yet recruiting there are no published results in the record. As development proceeds the project would likely be evaluated for predictive performance and clinical relevance. In the regulatory context MDR Annex XIV requires a defined intended use and a verifiable safety and performance case for devices that rely on software driven decisions. The entry does not claim clearance but signals the typical regulatory path for an assessment based tool that informs preoperative planning.

What safety and performance concerns should a reviewer watch?

Key considerations include how well the model generalizes to older adults undergoing diverse major noncardiac procedures and the risk of bias in input data. Regulators and sponsors would want evidence on calibration, discrimination and real world effectiveness. Clinicians should consider how results are presented and how they inform clinical judgment. The absence of results in the record means stakeholders must await validation studies and regulatory filings to assess risk and benefit more fully.

What are the next steps for this project?

If development continues the likely path involves formal study protocol completion data collection and prospective validation. Next steps would include performance reporting usability assessment and engagement with regulatory authorities to determine whether a device like this will require a clearance or approval pathway. The current record confirms not yet recruiting status and invites ongoing monitoring by regulatory minded readers.