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Feasibility and Utility of Artificial Intelligence (AI) / Machine Learning (ML) - Driven Advanced Intraoperative Visualization and Identification of Critical Anatomic Structures and Procedural Phases in Laparoscopic Cholecystectomy

NCT05775133 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-21

No results posted yet for this study

Summary

The goal of this study is to evaluate the utility and efficacy of an artificial intelligence (AI) model at identifying structures and phases of surgery compared to traditional white light assessment by trained surgeons. Surgeons will perform the procedure in their standard practice, while the AI model analyzes data from the laparoscopic camera. Surgeons will be asked to audibly state when they identify structures and enter different phases of the surgical procedure.

The AI will not alter the surgeon's view or be visible to the surgeon, and the surgeon will perform the procedure in the exact same fashion as they typically do.

Conditions

Interventions

DEVICE

ICG

Patient will receive a standard dose of indocyanine green (ICG) 45 minutes prior to surgery. ActivSight will be used during laparoscopic cholecystectomy - the surgeon will perform the procedure in their standard fashion. Video data will be analyzed in real-time by Activ Surgical's ActivInsight surgical artificial intelligence platform to identify anatomic structures and surgical phase. The surgeon will be blinded to this information, and will see the standard screens and information they do when performing the procedure in a non-study setting.

Sponsors & Collaborators

  • Activ Surgical

    lead INDUSTRY

Principal Investigators

  • Peter Kim, MD, PhD · Activ Surgical

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775133 on ClinicalTrials.gov