AI in Endoscopic Transsphenoidal Surgery

NCT07568366 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 127474
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pituitary Adenoma

Keywords

Artificial intelligence; computer vision; surgical technology; technology translation; pituitary adenoma; endoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Safety

  Perioperatively/periprocedurally (surgeon distraction, team disruption); and immediately after the intervention/procedure/surgery (output accuracy, volatility and latency)

• Educational yield

  Immediately after the intervention/procedure/surgery

• Surgical outcomes

  Through study completion, an average of 1 year

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Device: Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor

Interventions

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (above the age of 18 years old)
• Undergoing endoscopic transsphenoidal surgery
• Able to provide consent

You may not qualify if:

• Patients less than 18 years of age
• Undergoing transcranial surgery or microscopic transsphenoidal surgery
• Unable to provide consent e.g., cannot understand, mental illness, or later withdrawing consent

Sponsors & Collaborators

• University College London Hospitals: collaborator
• University College, London: lead

Study Sites (1)

National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 40702372 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.

  PMID: 36561572 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.

  PMID: 39127380 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.

  PMID: 39521895 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.

  PMID: 29697448 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Staged single centre non-comparative case series - IDEAL Stage 1 and 2a, evaluating feasibility and early safety respectively

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: To be specific in data transfer agreement
• Access Criteria: To be specific in data transfer agreement

Locations

GB (1)