ClinicalTrials.gg
Not yet recruitingNCT07927153Updated Nov 10, 2026

Prospective AI-SC Trial

An observational study in Liver Cirrhosis, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University Health Network, Toronto · Observational

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a prospective, pre-post implementation study designed to evaluate how artificial intelligence-based selection committee (AI-SC) recommendations affect decision-making when integrated into routine clinical workflows. The study will focus on individual liver transplant candidacy decisions as the primary unit of analysis. Researchers will observe and analyze these decisions during weekly University Health Network (UHN) Liver Transplant Selection Committee meetings over an approximate 12-month period. The goal is to determine if the deployment of AI-SC recommendations changes, optimizes, or influences the committee's final transplant candidacy determinations compared to baseline practices.

Read the detailed description

The study will be conducted over an approximate 12-month period during regular weekly UHN Liver Transplant Selection Committee meetings. The primary unit of analysis is the individual liver transplant candidacy decision. The AI-SC output is then presented as an advisory decision-support summary. The committee may maintain or modify its decision and/or rationale. The final decision remains the decision of the human committee.

The study utilizes a pre-post implementation design:

  1. Pre-Implementation Phase (Baseline): The committee will conduct evaluations and reach candidacy decisions according to standard clinical workflows without access to the AI tool.
  2. Post-Implementation Phase (Intervention): The committee will be presented with the AI-SC recommendations during their routine workflow before finalising the candidacy decision.

Objectives and Evaluated Metrics The primary objective is to evaluate the direct effect of AI-SC recommendations on committee decision-making when deployed prospectively.

To comprehensively assess this impact, the secondary objectives will systematically measure:

  • Decision Dynamics: The frequency and specific direction of transplant candidacy decision changes (e.g., from deferral to approval, or vice versa) following the introduction of AI-SC reviews.
  • Decision Quality and Rationale: The impact of the tool on the clinical rationale's quality, transparency, completeness, actionability, and perceived fairness.
  • Clinician Factors: Multi-disciplinary team members' confidence, acceptance, trust, perceived usefulness, and the overall workflow burden imposed by the tool.
  • Predictors of Influence: Patient- and case-specific characteristics that are statistically associated with AI-influenced decision changes.
  • Algorithmic Fairness and Equity: The consistency and fairness of the AI tool across diverse patient demographics and clinical profiles, specifically examining sex, race, ethnicity, height, ABO blood group, liver disease etiology, and Area Deprivation Index (ADI).
  • Operational Feasibility: System performance metrics including software uptime, error rates, and the tangible impact on weekly meeting duration.
  • Clinical Insight and Safety Catchment: Documentation of instances where the AI-SC successfully flags missing clinical data, guideline-relevant issues, potential contraindications, or overlooked clinical opportunities that were not emphasized during the initial multi-disciplinary discussion.

Eligibility Criteria:

Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Age 18 years or older.
  • Undergoing a liver transplant assessment at UHN.
  • Anticipated presentation and discussion at the weekly UHN Liver Transplant Selection Committee meeting.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Refusal or withdrawal of consent.
  • Cases for which required committee presentation information is unavailable to the study team.
  • Cases in which urgent clinical circumstances do not allow the informed consent process to occur prior to the scheduled committee review.
  • Cases in which the treating clinical team determines that research contact is inappropriate due to severe clinical, emotional, or logistical circumstances.
02

Conditions studied

  • Liver Cirrhosis

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Keywords

  • Prospective AI-SC Trial
03

In context

Liver Cirrhosis

1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.

This study's planned enrollment of 200 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with liver cirrhosis assessed for liver transplantation at UHN who may be presented at the weekly UHN Liver Transplant Selection Committee meeting.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 18 years or older; undergoing liver transplant assessment at UHN; anticipated discussion at the UHN liver transplant selection committee; ability to provide

Exclusion criteria

Exclusion Criteria:

  • refusal or withdrawal of consent; cases for which required committee presentation information is unavailable to the study team; cases in which urgent clinical circumstances do not allow the consent process to occur before committee review; cases in which the treating team determines that research contact is inappropriate because of clinical, emotional, or logistical circumstances.

Refusal to participate will not affect transplant assessment, committee review, clinical management, waitlist eligibility, or access to future care.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherArtificial Intelligence Selection Committee (AI-SC)

    The AI-SC is an investigational clinical decision-support tool designed to provide a structured advisory recommendation for liver transplant candidacy discussions. It consists of six specialty-specific LLM-based agents representing hepatology, transplant surgery, cardiology, anesthesiology, psychiatry, and social work. The system uses a retrieval-augmented generation framework that references a locked knowledge base of institutional transplant criteria and relevant clinical guidelines.

06

What researchers measure

Primary outcomes

  1. Frequency of modification of transplant committee decisions after presentation of the AI-SC recommendation, measured as the proportion of cases in which the final post-AI decision differs from the recorded initial pre-AI decision

    Time frame: During weekly UHN Liver Transplant Selection Committee meetings for approximately 12 months.

07

Study locations

1 site
  • Ajmera Transplant Centre, Toronto General Hospital, UHN
    Toronto, Ontario M5G 2N2, Canada
08

References and documents

Individual participant data

Plan to share: No — Participant privacy and confidentiality.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 12 months is below that.

Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 10, 2026
StartEst.
Nov 13, 2026
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2028
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927153
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Mamatha Bhat, MD, Principal Investigator
Contact
mamatha.bhat@uhn.ca
416-340-4800 ext. 6221
Peregrina Peralta, BSc CCRP, CRC II
Contact
peregrina.peralta@uhn.ca
416-340-4800 ext. 5979

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 Nov 2026. You cannot join it, but the record below documents what was studied.

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