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Ambient Audio-Visual Capture for Clinical Documentation and Assessment

NCT07649772 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-16

No results posted yet for this study

Summary

AI-powered tools that automatically document clinical conversations are being adopted rapidly in outpatient settings but have not been evaluated in hospital wards. Existing tools use audio recording only, which cannot capture physical examination findings, procedural observations, or clinical safety behaviours - elements of a ward round that are visible but not audible.

This study evaluates an ambient audio-visual (AV) capture system - BlackFrame - that uses both microphone and camera to generate accurate clinical documentation and structured educational feedback in a real inpatient surgical ward setting.

Medical students and doctors in training participate in supervised ward round encounters with consenting adult inpatients. The BlackFrame AI platform generates: (a) a structured draft clinical note for the supervising clinician to review and countersign before any use in the patient record; and (b) formative feedback for the trainee, delivered within 30 minutes, covering clinical communication, examination technique, and documentation quality.

The study measures whether AI-generated feedback improves trainee clinical performance over a placement, how much documentation time is saved, and whether the system is acceptable to patients and clinicians. No AI-generated text enters the patient record without explicit clinician review and sign-off. All participation is voluntary.

Conditions

  • Clinical Documentation
  • Artificial Intelligence
  • Surgical Education
  • Medical Education

Interventions

DEVICE

BlackFrame ambient audio-visual capture platform

Fixed camera and microphone array positioned visibly in the patient's room captures the ward round encounter. The AI platform processes the recording to generate: (a) a structured draft clinical note for supervising clinician review and countersignature; (b) a formative feedback report for the trainee covering clinical communication, examination technique, and documentation quality, delivered within 30 minutes of the encounter.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Somerset NHS Foundation Trust

    collaborator OTHER

  • BlackFrame.ai

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649772 on ClinicalTrials.gov