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Not yet recruitingNCT07568366Updated May 5, 2026

AI in Endoscopic Transsphenoidal Surgery

An Early Phase 1 interventional study of Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor in Pituitary Adenoma, sponsored by University College, London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University College, London · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Pituitary Adenoma

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Keywords

  • Artificial intelligence
  • computer vision
  • surgical technology
  • technology translation
  • pituitary adenoma
  • endoscopic surgery
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In context

Pituitary Neoplasms

175 studies on the registry are indexed under Pituitary Neoplasms; 48 are open to participants now.

This study's planned enrollment of 30 is below the median of 55 across 98 interventional studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention Arm

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

Interventions

  • DeviceLive intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor

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

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What researchers measure

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).

    Time frame: Immediately after the intervention/procedure/surgery

Secondary outcomes

  1. Safety

    * observation for operating surgeon distraction: recorded as discrete instances of unplanned disruption of primary surgeon workflow per surgery, as observed by observer from research team * wider surgical team workflow disruption : recorded as discrete instances of unplanned disruption of wider surgical team workflow per surgery, as observed by observer from research team * AI output inaccuracy and volatility: measured via sampling of 3-5x clips (30-60sec at 5fps) during which surgical scene is static (i.e. during routine anatomical verification checks), and calculating DICE scores (vs groundtruth segmentations) for accuracy estimation and DICE/sec for volatility estimatipon. * AI output latency: measured as discrete instances of unacceptably elevated latency (\>200ms) of the AI output display vs the primary direct surgical feed, as observed by observer from research team.

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

  2. Educational yield

    To evaluate the utility of the platform for educational purposes. Via structured educational yield questionnaire of surgeons involved in each case

    Time frame: Immediately after the intervention/procedure/surgery

  3. Surgical outcomes

    * Surgical performance vs matched cohort: measured via modified OSATS on independent surgical video review * Surgical outcomes vs matched cohort: measured via comparative analysis of standardised outcome set

    Time frame: Through study completion, an average of 1 year

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Study locations

1 site
  • National Hospital for Neurology and Neurosurgery
    London, United Kingdom
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References and documents

Publications

  • 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. PubMed 40702372 ↗
  • 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. PubMed 36561572 ↗
  • 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. PubMed 39127380 ↗
  • 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. PubMed 39521895 ↗
  • 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. PubMed 29697448 ↗

Individual participant data

Plan to share: Yes — Available upon formal reasonable request

Supporting information: Study protocol, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07568366
Lead sponsor
University College, London
Collaborators
University College London Hospitals
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Aug 1, 2028 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
May 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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