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AI in Endoscopic Transsphenoidal Surgery

30. april 2026 opdateret af: University College, London

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Arm
Enhed: Live 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of live AI video analysis
Tidsramme: Immediately after the intervention/procedure/surgery
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety
Tidsramme: Perioperatively/periprocedurally (surgeon distraction, team disruption); and immediately after the intervention/procedure/surgery (output accuracy, volatility and latency)
  • 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.
Perioperatively/periprocedurally (surgeon distraction, team disruption); and immediately after the intervention/procedure/surgery (output accuracy, volatility and latency)
Educational yield
Tidsramme: Immediately after the intervention/procedure/surgery

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
Tidsramme: Through study completion, an average of 1 year
  • 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
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Samarbejdspartnere

University College London Hospitals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

31. januar 2029

Datoer for studieregistrering

Først indsendt

30. marts 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 127474

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Available upon formal reasonable request

IPD-delingstidsramme

To be specific in data transfer agreement

IPD-delingsadgangskriterier

To be specific in data transfer agreement

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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