CholelithiasisNCT06852937
Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
A study testing da Vinci SP Surgery System in people with Cholelithiasis and Choledocholithiasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cholelithiasis, Choledocholithiasis
- What is being tested?
- da Vinci SP Surgery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Dec 2024to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 years or more
- Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chronic cholecystitis with or without biliary tract injury or stricture
- Indication of cholecystectomy with or without common bile duct exploration and deemed feasible for robotic surgery
- Patient not feasible or have failed stone extraction or intervention for choledocholithiasis by endoscopic retrograde cholangiopancreatography for patients with choledocholithiasis could be included
- ASA physical status classification 1-2 and adequate organ function
- Patients willing and able to comply with study protocol requirements and follow-up
- Patients who are taking anti-platelet or anti-coagulation medications are eligible for this trial, but the associated agents should be discontinued 5 days prior to the operation day. Patients who are taking Wafarin should be admitted two days earlier for bridging to Heparin. Other medications for underlying diseases can be taken as usual.
- With informed consent
Who cannot join
- Severe acute cholecystitis
- Suspected biliary tract cancer or untreated biliary tract cancer
- BMI ≥35 or BMI <18.5
- Unable to tolerate robotic surgery position
- Severe adhesion due to prior abdominopelvic surgery
- Prior major upper abdominal surgery judged by the investigator as not feasible for robotic surgery
Show all 12Show fewer
- Active infectious disease
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class III-IV) or severe lung disease (GOLD Group C-D)
- Cannot follow trial-required procedures
- Concomitant systemic or pelvic disease that increases the risk of surgery
- Patients with coagulopathy
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis
A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)
Read the detailed description
Cholelithiasis (gallstones) is a common disease of digestive tract in adults. It has been reported that 5-10% or 2 million of Taiwanese adults have gallstones according to National Health Insurance Administration.
Laparoscopic cholecystectomy is deemed a surgical standard of care for its safety, effectiveness, and benefits: less post-operative pain, faster recovery, shorter hospital stay, and better cosmesis. However, the advantages of da Vinci surgical system include enhanced vision, wristed instruments, and dexterity of control.
Robotic cholecystectomy by single-port SP system is associated with shorter operation time, shorter dissection time, and less post-operative pain.
Further improvement in robotic cholecystectomy with CBDE regarding cosmesis and patient satisfaction could be made by adopting da Vinci SP system which preserves enhanced vision and instrument dexterity with only one access port. So far there is no published data on robotic cholecystectomy with CBDE using da Vinci SP. Current study is set forth to evaluate technical feasibility and clinical outcome of robotic biliary surgery using da Vinci SP Surgical System for patients with complex cholelithiasis.
- Conditions
- Cholelithiasis, Choledocholithiasis
- Being tested
- da Vinci SP Surgery System
- Medical subject headings
- Cholelithiasis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci SP Surgery SystemDevice
da Vinci SP Surgery System
| Study group | Role | What they receive |
|---|---|---|
| Operation of focus procedure with da Vinci SP Surgery System | Experimental | Operation of cholecystectomy and common bile duct exploration with da Vinci SP Surgery System Receives: Device: da Vinci SP Surgery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of conversion rate
The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.
Measured: During Surgery
Secondary outcomes (1)
Incidence of Treatment Emergent Adverse Events
The safety endpoint will be assessed as the incidence of all intra-operatvie and post-operative adverse events that occur through the follow up period.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start21 Dec 2024
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Yao-Ming Wu, Principal investigator, Vice Superintendent of NTUCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852937
- Sponsor's protocol ID
- 202409006DIPD
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis
- ClinicalTrials.gov ID
- NCT06852937
- Acronym / sponsor ID
- 202409006DIPD
- Conditions
- Cholelithiasis, Choledocholithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 21 Dec 2024 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 28 Feb 2025 (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.
A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)
Detailed description
Cholelithiasis (gallstones) is a common disease of digestive tract in adults. It has been reported that 5-10% or 2 million of Taiwanese adults have gallstones according to National Health Insurance Administration.
Laparoscopic cholecystectomy is deemed a surgical standard of care for its safety, effectiveness, and benefits: less post-operative pain, faster recovery, shorter hospital stay, and better cosmesis. However, the advantages of da Vinci surgical system include enhanced vision, wristed instruments, and dexterity of control.
Robotic cholecystectomy by single-port SP system is associated with shorter operation time, shorter dissection time, and less post-operative pain.
Further improvement in robotic cholecystectomy with CBDE regarding cosmesis and patient satisfaction could be made by adopting da Vinci SP system which preserves enhanced vision and instrument dexterity with only one access port. So far there is no published data on robotic cholecystectomy with CBDE using da Vinci SP. Current study is set forth to evaluate technical feasibility and clinical outcome of robotic biliary surgery using da Vinci SP Surgical System for patients with complex cholelithiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operation of focus procedure with da Vinci SP Surgery System | Experimental | Device: da Vinci SP Surgery SystemOperation of cholecystectomy and common bile duct exploration with da Vinci SP Surgery System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20 years or more
- Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chronic cholecystitis with or without biliary tract injury or stricture
- Indication of cholecystectomy with or without common bile duct exploration and deemed feasible for robotic surgery
- Patient not feasible or have failed stone extraction or intervention for choledocholithiasis by endoscopic retrograde cholangiopancreatography for patients with choledocholithiasis could be included
- ASA physical status classification 1-2 and adequate organ function
Key exclusion criteria (12 listed)
- Severe acute cholecystitis
- Suspected biliary tract cancer or untreated biliary tract cancer
- BMI ≥35 or BMI <18.5
- Unable to tolerate robotic surgery position
- Severe adhesion due to prior abdominopelvic surgery
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 |
|---|---|---|
| da Vinci SP Surgery Systemda Vinci SP Surgery System | Device | Operation of focus procedure with da Vinci SP Surgery System |
Primary outcome
Incidence of conversion rate
Time frame: During Surgery
The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.
1 secondary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cholelithiasis
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Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
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Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
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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.
Yao-Ming Wu principal investigator
Vice Superintendent of NTUCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci SP Surgery System in people with Cholelithiasis and Choledocholithiasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 17 Sep 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of conversion rate (time frame: During Surgery). 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 17 Sep 2026.