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Pituitary AdenomaEarly Phase 1NCT07568366

AI in Endoscopic Transsphenoidal Surgery

A Early Phase 1 study testing Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor in people with Pituitary Adenoma, run by University College, London at 1 site in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pituitary Adenoma
What is being tested?
Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
1 Jun 2026to 31 Jan 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site

  • National Hospital for Neurology and Neurosurgery

    London

Other trials in United Kingdom

About this study

Official title: The Application of Artificial Intelligence to Patients Undergoing Endoscopic Transsphenoidal Surgery: a Single-site Prospective Feasibility and Exploratory Study (IDEAL Stage 1 and 2a)

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).

Being tested
Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor
Keywords
Artificial intelligence, computer vision, surgical technology, technology translation, pituitary adenoma, endoscopic surgery
Medical subject headings
Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT07568366
Study groupRoleWhat they receive
Intervention ArmExperimentalNot described
Receives: Device: Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Immediately after the intervention/procedure/surgery

Secondary outcomes (3)

  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.

    Measured: 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

    Measured: 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

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Staged single centre non-comparative case series - IDEAL Stage 1 and 2a, evaluating feasibility and early safety respectively
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07568366
Sponsor's protocol ID
127474
Status last verified
Apr 2026
First submitted
30 Mar 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Available upon formal reasonable request

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Live intra-op AI analysis of endoscopic video feed, with output displayed on supplementary monitor in people with Pituitary Adenoma, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of live AI video analysis (time frame: Immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07568366, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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