AI-Assisted Cholecystectomy Study

NCT07705828 | Active Not Recruiting

• 1 other identifier: CRE-2026.237
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Gallstones; Gallbladder Polyp

Keywords

Cholecystectomy; Surgical robot Sentire; AI-assisted surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intraoperative and Postoperative Complications rate

  30 days

• Subjective Assessment of System Performance and Controllability

  1 day

• Objective Assessment of System Performance and Controllability

  1 day

Study Arms (1)

Robotic Assisted Laparoscopic Cholecystectomy Group

EXPERIMENTAL

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

Interventions

AI-Assisted Cornerstone Robotics Sentire Surgical System DEVICE

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.

Robotic Assisted Laparoscopic Cholecystectomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)