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← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2023-508316-27-00

Preoperative Indocyanine Green administration increases intraoperative detection of Liver Tumors in Imaging-guided surgery. A phase IV clinical trial.

Public registry stateAuthorised
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2023-508316-27-00
Trial status
Authorised
Sponsor
not published
Trial region
EEA
Phase
6
Trial category
3
Low-intervention trial
yes
Estimated EU start
10 June 2024
Decision date
12 February 2024
Published
17 July 2026
Estimated end
01 February 2027
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“…o analyze the detection of liver tumors using indocyanine green fluorescence uptake in combination with intraoperative ultrasonography and preoperative imaging test • To develop a machine-learning algorithm to detect liver tumors with indocyanine green by photographic analysis.”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.mainObjective
Matched term
machine learning
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Patients with liver tumors that will undergo minimally invasive liver surgery

Therapeutic areas

  • Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]27
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Spain

Authorised
First decision
12 February 2024
Latest decision
16 July 2026
  1. Authorised
  2. Authorised
  3. Authorised
  4. Authorised
  5. Authorised
  6. Authorised
  7. Authorised
  8. Authorised
  9. Authorised
  10. Authorised
  11. Authorised
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN

INITIAL

Authorised
Trial status
Authorised
Submitted
28 November 2023
Decided
12 February 2024

Decisions12 February 2024 · Authorized

Country statusSpain · Authorised

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
06 March 2024
Decided
03 May 2024

Decisions03 May 2024 · Authorized

Country statusSpain · Authorised

SM-2

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
27 March 2025
Decided
29 May 2025

Decisions29 May 2025 · Authorized

Country statusSpain · Authorised

SM-3

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
29 May 2025
Decided
30 May 2025

Decisions30 May 2025 · Authorized

SM-4

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
25 August 2025
Decided
29 August 2025

Decisions29 August 2025 · Authorized

Country statusSpain · Authorised

SM-5

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
09 June 2026
Decided
16 July 2026

Decisions16 July 2026 · Authorized

Country statusSpain · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN · Authorised

  2. Country Assessment

    Spain · Application IN · Authorized

  3. Application Status

    Application IN · Authorised

  4. Country Decision

    Spain · Application IN · Authorized

  5. Application Submitted

    Application SM-1 · Authorised

  6. Country Assessment

    Spain · Application SM-1 · Authorized

  7. Application Status

    Application SM-1 · Authorised

  8. Country Decision

    Spain · Application SM-1 · Authorized

  9. Application Submitted

    Application SM-2 · Authorised

  10. Country Assessment

    Spain · Application SM-2 · Authorized

  11. Application Status

    Application SM-2 · Authorised

  12. Application Submitted

    Application SM-3 · Authorised

  13. Country Decision

    Spain · Application SM-2 · Authorized

  14. Application Status

    Application SM-3 · Authorised

  15. Country Decision

    Spain · Application SM-3 · Authorized

  16. Application Submitted

    Application SM-4 · Authorised

  17. Country Assessment

    Spain · Application SM-4 · Authorized

  18. Application Status

    Application SM-4 · Authorised

  19. Country Decision

    Spain · Application SM-4 · Authorized

  20. Application Submitted

    Application SM-5 · Authorised

  21. Application Status

    Application SM-5 · Authorised

  22. Country Assessment

    Spain · Application SM-5 · Authorized

  23. Country Decision

    Spain · Application SM-5 · Authorized

  24. Trial Status Observed

    Authorised

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓
i6eal (2026): EU AI Studies Monitor, CTIS trial 2023-508316-27-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2023-508316-27-00/
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