AI-Assisted Cholecystectomy Study

AI-Assisted Cholecystectomy With Laparoscopic Surgical Robot: A First-in-Human Study

The objective of this prospective clinical pilot study is to evaluate the clinical feasibility, safety, and workflow integration of the voice-based AI-assisted robotic system for performing selected auxiliary tasks during robotic cholecystectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Gallbladder Polyp; Symptomatic Gallstones
• Intervention / Treatment: Device: AI-Assisted Cornerstone Robotics Sentire Surgical System

Detailed Description

Robotic-assisted surgery provides surgeons with enhanced dexterity, stable three-dimensional visualization, and improved ergonomics for minimally invasive procedures. However, despite these technological advances, complex robotic operations remain cognitively demanding and highly coordinated. In addition to controlling the primary operative instruments, surgeons are required to manage auxiliary tasks such as tissue retraction, maintenance of surgical exposure, and coordination of multiple robotic arms. These auxiliary tasks often require frequent switching between control modes, manual adjustments, or verbal coordination with clinical assistants, which may interrupt surgical flow and increase cognitive workload.

In current clinical practice, maintaining stable and optimal exposure of the surgical field is essential for safe dissection and precise manipulation. Elective robotic or laparoscopic cholecystectomy is a standardized and well-established surgical procedure that involves repetitive and well-defined sub-tasks such as tissue retraction, exposure adjustment, and cystic duct and artery clipping. During this procedure, surgeons must repeatedly adjust retraction direction and tension in response to anatomical variation, tissue deformation, and procedural progression. These adjustments are commonly performed by manually controlling an additional robotic arm or by communicating with an assistant surgeon. Such workflows may divert attention from the primary operative task and increase the risk of inefficiency or distraction, particularly during delicate dissection near critical anatomical structures.

To address the challenges associated with auxiliary task management in robotic surgery, we propose a novel voice-assisted automated "third hand" system for supervised surgical assistance. Recent advances in artificial intelligence, robotic perception, and natural language processing have enabled the development of interactive systems capable of understanding spoken commands and executing structured actions in real time. Prior work suggests that voice-based interaction can be feasibly applied in human-machine and human-robot collaboration, indicating its potential as a hands-free control interface [1,2]. At the same time, progress in task-specific robotic control has made it increasingly feasible to deploy limited, well-defined automation under continuous human supervision. Together, these developments create opportunities for designing intelligent assistive systems that support surgical workflow while preserving surgeon authority and responsibility.

The proposed system integrates a natural language interface with task-specific robotic control to enable surgeons to verbally command and adjust a dedicated robotic arm responsible for tissue retraction, exposure maintenance, and selected repetitive actions. Through predefined motion constraints, force limits, and continuous monitoring, the system is designed to function as an assistive tool rather than an autonomous decision-making agent. The surgeon remains fully responsible for procedural planning and execution and may interrupt or override automated actions at any time. The research team has successfully undergone multiple pre-clinical trials including ex-vivo porcine, live porcine as well as cadaveric procedures, confirming the safety of the AI system. (Refer to "Prior Study" section) Elective robotic cholecystectomy provides an appropriate experimental model for evaluating this approach due to its standardized workflow and frequent requirement for dynamic exposure adjustment. By delegating selected auxiliary tasks to an AI-controlled robotic arm while maintaining continuous surgeon supervision, this study enables systematic evaluation of the feasibility, controllability, and safety of limited, task-specific automation. This experiment, therefore, proposes a clinical first-in-human pilot study to evaluate a collaborative surgical framework in which an automated third hand executes constrained sub-tasks under direct surgeon oversight, while voice commands are used to dynamically adjust and coordinate robotic behavior during surgery, without replacing surgeon judgment or decision-making

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18 years, and
• Body mass index <35kg/m2, and
• Scheduled for elective laparoscopic / robotic cholecystectomy for symptomatic gallstones or gallbladder polyp, and
• American Society of Anesthesiologist (ASA) I-III

Exclusion Criteria:

• Contraindication to general anaesthesia
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Past history of cholecystitis, liver abscess, Mirizzi syndrome
• Contracted gallbladder or dilated common bile duct on pre-operative imaging
• Known (Child's B or above) liver cirrhosis
• Uncorrectable coagulopathy
• Previous upper abdominal open surgery
• Presence of another malignancy or distant metastasis
• Emergency surgery
• Vulnerable population (e.g. mentally incapacitated or pregnant persons)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Robotic Assisted Laparoscopic Cholecystectomy Group; The procedure would be performed as per robotic assisted cholecystectomy with 4-port techniques. After putting under general anaesthesia, a peri-umbilical camera port will be inserted with open technique, followed by introduction of capnoperitoneum at pressure of 12mmHg. Three additional working ports will be inserted in the upper abdomen under direct laparoscopic vision. Docking of Sentire surgical robotic system would then be carried out, with subsequent procedure performed by the surgeon at the console. The Calot's triangle would be dissected first with identification of cystic duct and artery to achieve the critical view of safety. After ligation of both cystic artery and duct, the gallbladder would be dissected from the liver bed, and retrieved from the peri-umbilical port site in a plastic bag. The insertion of abdominal drain would be upon discretion of the operating surgeon. The entire procedure would follow the important surgical principles in preventing bile duct injury or o

Device: AI-Assisted Cornerstone Robotics Sentire Surgical System; Robotics Sentire Surgical System is a software-controlled, electromechanical system designed and approved for surgeons to perform MIS in the thorax and abdomen. The operating surgeon sits at the surgeon console, views the surgical site in a high resolution three-dimensional stereo viewer, and controls movements of the EndoWrist instruments and the camera using two master controllers and a set of foot pedals. The vision cart includes the supporting electronic and video processing equipment for the system. The system utilizes one designated robotic manipulator as an assistive arm dedicated to exposure management and auxiliary task support during surgery. This assistive arm is configured to operate independently from the primary operative instruments and is assigned specifically for tissue retraction, vessel/duct clipping, and maintenance of the surgical field. Its motion and interaction with tissue are governed by task-specific control algorithms and predefined safety constraints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	Clinical success refers to completion of the intended cholecystectomy incorporating the AI system without conversion to conventional robot (without AI assistant), laparoscopy, or open surgery, and without intra-operative complication.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative and Postoperative Complications rate	Safety data will include all intraoperative and postoperative complications occurring within 30 days following surgery. Complications will be classified according to standard clinical reporting criteria, including the Clavien-Dindo classification of surgical complications.	30 days
Subjective Assessment of System Performance and Controllability	Subjective performance assessment will be conducted using modified task-specific evaluation forms adapted from validated surgical skill assessment tools. Evaluation will be conducted by the operating surgeon, assisting surgeon, and an independent evaluator, focusing on exposure stability, retraction effectiveness, precision of positioning, and integration with primary surgical workflow.	1 day
Objective Assessment of System Performance and Controllability	Objective metrics to be analyzed include: Number of retraction adjustments required to maintain adequate exposure during dissection.; Number of activation failures for the voice command.; Number of uses of the emergency stop mechanism during the AI automation.	1 day

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cholecystectomy; Surgical robot Sentire; AI-assisted surgery
• Other Study ID Numbers: CRE-2026.237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No