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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
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This study focuses on bringing artificial intelligence into the operating room to assist with pituitary tumour surgeries performed through the nose. These procedures are technically demanding, and training new surgeons is often inconsistent. To address this, researchers at the National Hospital for Neurology and Neurosurgery are testing AI systems that "watch" surgical videos in real-time to identify anatomy, instruments, and the specific phase of the operation.
The core goal of the prospective trial is to improve education and team coordination without interfering with the surgery itself. The AI displays its analysis on tablets positioned for the surgical residents and nurses, rather than the lead surgeon. This setup allows the team to follow the procedure's progress, key anatomy and anticipate next steps without the surgeon needing to stop and explain. Because hospital internet can be unreliable, the study is prioritizing specialized hardware from NVIDIA that processes data locally. This "edge computing" approach ensures the AI is fast and doesn't require a live cloud connection to function.
This trial will assess the device feasibility (IDEAL Stage 1 study, ~6 cases), followed by early safety and system technical refinement (IDEAL 2a study, ~20-30 cases).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor | Device | Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of live AI video analysis | The primary objective of this study is to evaluate the feasibility of the TouchSurgery platform or NVIDIA AGx/IGx based platforms for prospective AI-based surgical video analysis (via observation, validated implementation assessment and human factors questionnaires; and semi-structured interviews of surgical team members). | Immediately after the intervention/procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
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The inclusion criteria will be:
The exclusion criteria will be:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital for Neurology and Neurosurgery | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40702372 | Background | Valetopoulou A, Newall N, Khan DZ, Borg A, Bouloux PMG, Bremner F, Buchfelder M, Cudlip S, Dorward N, Drake WM, Fernandez-Miranda JC, Fleseriu M, Geltzeiler M, Ginn J, Gurnell M, Harris S, Jaunmuktane Z, Korbonits M, Kosmin M, Koulouri O, Horsfall HL, Mamelak AN, Mannion R, McBride P, McCormack AI, Melmed S, Miszkiel KA, Raverot G, Santarius T, Schwartz TH, Serrano I, Zada G, Baldeweg SE, Marcus HJ, Kolias AG; PitCOP Collaborators. A core outcome set for pituitary surgery research: an international delphi consensus study. Pituitary. 2025 Jul 23;28(4):88. doi: 10.1007/s11102-025-01553-w. | |
| 36561572 |
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Available upon formal reasonable request
To be specific in data transfer agreement
To be specific in data transfer agreement
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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Staged single centre non-comparative case series - IDEAL Stage 1 and 2a, evaluating feasibility and early safety respectively
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| Perioperatively/periprocedurally (surgeon distraction, team disruption); and immediately after the intervention/procedure/surgery (output accuracy, volatility and latency) |
| Educational yield | To evaluate the utility of the platform for educational purposes. Via structured educational yield questionnaire of surgeons involved in each case | Immediately after the intervention/procedure/surgery |
| Surgical outcomes |
| Through study completion, an average of 1 year |
| Background |
| Newall N, Khan DZ, Hanrahan JG, Booker J, Borg A, Davids J, Nicolosi F, Sinha S, Dorward N, Marcus HJ. High fidelity simulation of the endoscopic transsphenoidal approach: Validation of the UpSurgeOn TNS Box. Front Surg. 2022 Dec 6;9:1049685. doi: 10.3389/fsurg.2022.1049685. eCollection 2022. |
| 39127380 | Background | Khan DZ, Newall N, Koh CH, Das A, Aapan S, Layard Horsfall H, Baldeweg SE, Bano S, Borg A, Chari A, Dorward NL, Elserius A, Giannis T, Jain A, Stoyanov D, Marcus HJ. Video-Based Performance Analysis in Pituitary Surgery - Part 2: Artificial Intelligence Assisted Surgical Coaching. World Neurosurg. 2024 Oct;190:e797-e808. doi: 10.1016/j.wneu.2024.07.219. Epub 2024 Aug 8. |
| 39521895 | Background | Khan DZ, Valetopoulou A, Das A, Hanrahan JG, Williams SC, Bano S, Borg A, Dorward NL, Barbarisi S, Culshaw L, Kerr K, Luengo I, Stoyanov D, Marcus HJ. Artificial intelligence assisted operative anatomy recognition in endoscopic pituitary surgery. NPJ Digit Med. 2024 Nov 9;7(1):314. doi: 10.1038/s41746-024-01273-8. |
| 29697448 | Background | Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794. |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |