Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe acute cholecystitis
Suspected biliary tract cancer or untreated biliary tract cancer
BMI ≥35 or BMI <18.5
Unable to tolerate robotic surgery position
Trial design
Design model
Single group
Treatments tested in this trial
da Vinci SP Surgery System
Deviceda Vinci SP Surgery System
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Operation of focus procedure with da Vinci SP Surgery SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During SurgerySecondary 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.
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Intuitive Surgical
Collaborator
Source ClinicalTrials.gov