Symptomatic GallstonesNCT07705828
AI-Assisted Cholecystectomy Study
A study testing AI-Assisted Cornerstone Robotics Sentire Surgical System in people with Symptomatic Gallstones and Gallbladder Polyp, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Gallstones, Gallbladder Polyp
- What is being tested?
- AI-Assisted Cornerstone Robotics Sentire Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Previous upper abdominal open surgery
- Presence of another malignancy or distant metastasis
- Emergency surgery
- Vulnerable population (e.g. mentally incapacitated or pregnant persons)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
Hong Kong
About this study
Official title: 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.
Read the 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
- Conditions
- Symptomatic Gallstones, Gallbladder Polyp
- Being tested
- AI-Assisted Cornerstone Robotics Sentire Surgical System
- Keywords
- Cholecystectomy, Surgical robot Sentire, AI-assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Cornerstone Robotics Sentire Surgical SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: AI-Assisted Cornerstone Robotics Sentire Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2026
- Primary completion31 May 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic GallstonesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705828
- Sponsor's protocol ID
- CRE-2026.237
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Cholecystectomy With Laparoscopic Surgical Robot: A First-in-Human Study
- ClinicalTrials.gov ID
- NCT07705828
- Acronym / sponsor ID
- CRE-2026.237
- Conditions
- Symptomatic Gallstones, Gallbladder Polyp
- Keywords
- Cholecystectomy, Surgical robot Sentire, AI-assisted surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Laparoscopic Cholecystectomy Group | Experimental | Device: AI-Assisted Cornerstone Robotics Sentire Surgical SystemThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Assisted Cornerstone Robotics Sentire Surgical SystemRobotics 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. | Device | Robotic Assisted Laparoscopic Cholecystectomy Group |
Primary outcome
Clinical success rate
Time frame: 1 day
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.
3 secondary outcomes
Intraoperative and Postoperative Complications rate
Time frame: 30 days
Subjective Assessment of System Performance and Controllability
Time frame: 1 day
Objective Assessment of System Performance and Controllability
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Cornerstone Robotics Sentire Surgical System in people with Symptomatic Gallstones and Gallbladder Polyp, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.