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 | Recruiting FDA Device

• 1 other identifier: 20220620
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Cholecystitis; Cholelithiasis; Biliary Dyskinesia

Keywords

artificial intelligence; laparoscopy; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Precision and accuracy

  Precision and accuracy of AI/ML model at identifying procedural phases and critical anatomic structures in laparoscopic cholecystectomy (LC). Precision will be calculated as True Positives / (True Positives + False Positives) Accuracy will be calculated as (True Positives + True Negatives) / Total Samples "True Positive" will be when the AI correctly identifies a procedural phase or critical anatomic structure. "False Positive" will be when it incorrectly labels a procedural phase or critical anatomic structure as the phase or structure of interest. "True Negatives" will be when the AI model correctly labels the phase or structure as not the label of interest. Accuracy and precision will be determined for each of the following labels: * each of three procedural phases (pre-, intra-, and post-gallbladder dissection) * each of seven biliary structures: gallbladder, cystic duct, common hepatic duct, common bile duct, cystic artery, region of interest, danger zone

  Immediately after each procedure

Secondary Outcomes (4)

• Length of procedure

  Immediately after each procedure

• Conversion rate to open procedure

  Immediately after each procedure

• Complication rate

  One month after each procedure

• Length of hospital stay

  One month after each procedure

Study Arms (2)

Indocyanine green (ICG)

EXPERIMENTAL

Patients in this arm will receive an intravenous injection of indocyanine green (ICG) 45 minutes prior to the start of surgery. This will be used to visualize the biliary anatomy using ActivSight, a device that is FDA 510(k)-cleared for this indication. The surgeon will perform the procedure in their standard fashion using ActivSight. ActivInsight artificial intelligence will be used to analyze the surgical video in real time to identify anatomic structures and phases of surgery.

Device: ICG

Non-Indocyanine Green (Non-ICG)

NO INTERVENTION

The surgeon will perform the procedure in their standard fashion without the use of ICG. ActivInsight artificial intelligence will be used to analyze the surgical video in real time to identify anatomic structures and phases of surgery.

Interventions

ICG DEVICE

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.

Indocyanine green (ICG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age \> 18 years old who are planned for elective laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
• Eligible patients will be screened and assigned as per risk calculator for difficulty of LC
• Diagnosis:
• All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
• Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
• Prior therapy:
• o Patients with prior surgery are eligible for enrollment.
• Laboratory:
• Hemoglobin \> 9 g/dL
• Platelet count ≥75,000/µL (may receive transfusions)
• Normal prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) \< 1.5 x upper limit of normal (including patients on prophylactic anticoagulation)
• Liver Function Test
• Renal function: Age-adjusted normal serum creatinine
• Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry \>94% on room air if there is any clinical indication for determination.

You may not qualify if:

• Non-elective acute cholecystectomy will be excluded.
• Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
• Patients currently in any investigational agents.
• Adults unable to consent
• Individuals under 18 years of age
• Pregnant women
• Prisoners
• Vulnerable populations

Sponsors & Collaborators

• Activ Surgical: lead

Study Sites (1)

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Cholecystitis; Cholelithiasis; Biliary Dyskinesia

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Study Officials

• Peter Kim, MD, PhD

  Activ Surgical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher McCulloh, MD

CONTACT

617-333-8162; cmcculloh@activsurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 20, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)