Clinical trial · Interventional
AI in Endoscopic Transsphenoidal Surgery
The Application of Artificial Intelligence to Patients Undergoing Endoscopic Transsphenoidal Surgery: a Single-site Prospective Feasibility and Exploratory Study (IDEAL Stage 1 and 2a)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- interventionNames
- Device: Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor
Primary outcomes (1)
- measure
- Feasibility of live AI video analysis
- timeFrame
- Immediately after the intervention/procedure/surgery
- description
- 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).
Secondary outcomes (3)
- measure
- Safety
- timeFrame
- Perioperatively/periprocedurally (surgeon distraction, team disruption); and immediately after the intervention/procedure/surgery (output accuracy, volatility and latency)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The inclusion criteria will be: 1. Adult patients (above the age of 18 years old) 2. Undergoing endoscopic transsphenoidal surgery 3. Able to provide consent The exclusion criteria will be: 1. Patients less than 18 years of age 2. Undergoing transcranial surgery or microscopic transsphenoidal surgery 3. Unable to provide consent e.g., cannot understand, mental illness, or later withdrawing consent
References
Publications (5)
- BACKGROUNDValetopoulou 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. PMID 40702372
- BACKGROUNDNewall 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. PMID 36561572
- BACKGROUNDKhan 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. PMID 39127380
- BACKGROUNDKhan 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. PMID 39521895
- BACKGROUNDHirst 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. PMID 29697448