[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641792":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":31,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":24,"maxAge":24,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":72,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":24},{"fullName":5,"class":6},"BlackFrame.ai","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trainee participants","EXPERIMENTAL","Medical students (Year 3-5) and doctors in training (FY1 through registrar\u002FST grade) undertaking supervised clinical activities on the surgical ward at the study site. Participants receive AI-generated formative feedback within 30 minutes of each ward round encounter and complete baseline and follow-up clinical assessments.",[13],"Device: BlackFrame ambient audio-visual capture platform",{"label":15,"type":10,"description":16,"interventionNames":17},"Patient participants","Adult inpatients aged 18 or over admitted under the surgical team at the study site, able to provide informed consent and clinically stable at the time of approach. Patients consent to ambient AV recording of their ward round encounter. Their care is unaffected by participation.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"George Ryan","CONTACT","+447946196325","georgeryan448@msn.com",{"type":32,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[34,37],{"name":35,"class":36},"The Cleveland Clinic","OTHER",{"name":38,"class":36},"Somerset NHS Foundation Trust","100641792","ambient-audio-visual-capture-for-clinical-documentation-and-assessment-100641792",false,"NCT07649772","Ambient Audio-Visual Capture for Clinical Documentation and Assessment","Ambient Audio-Visual Capture for Clinical Documentation, Assessment and Feedback in Medical Education","BLACKFRAME-AV-","Inclusion\n\nTrainee participants:\n\n* Doctor in training (FY1 through registrar\u002FST grade) undertaking a supervised clinical activity at a participating NHS study site\n* Able to provide written informed consent in English\n\nPatient participants:\n\n* Adult inpatient aged 18 years or over\n* Able to provide written informed consent in English\n* Admitted under a surgical team at a participating study site\n* Clinically stable at the time of approach\n\nExclusion\n\nTrainee participants:\n\n* Unwilling to be audio-visually recorded\n* Unable to provide written informed consent\n* Any trainee where participation could create a direct conflict with a concurrent formal assessment or appraisal process at that session\n\nPatient participants:\n\n* Age under 18 years\n* Unable to provide informed consent (including temporary incapacity due to acute illness, sedation, or delirium)\n* Acute clinical deterioration at the time of approach\n* Encounter involves sensitive disclosures in mental health, sexual health, or safeguarding unless a specific sub-protocol with additional consent measures is in place\n* Patient has previously declined participation and does not wish to be re-approached\n* Non-English speaking patients where no appropriate interpreter is available to support the consent process",true,"ALL",{"count":50,"type":51},60,"ESTIMATED","INTERVENTIONAL",[54],"NA","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.\n\nThis 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.\n\nMedical 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.\n\nThe 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.",[57,58,59,60],"Clinical Documentation","Artificial Intelligence","Surgical Education","Medical Education",[62,63,64,65,66,67,68,69,70,71],"ambient scribe","audio-visual capture","ward round","formative feedback","clinical assessment","AI documentation","inpatient","software as a medical device","inter-rater reliability","trainee assessment","NOT_YET_RECRUITING","2026-06-10",{"date":75,"type":76},"2026-06-16","ACTUAL",{"date":78,"type":51},"2026-09-01",{"date":80,"type":51},"2026-11-30",{"name":5,"class":6}]