BridgeMD
New treatment option for Cholelithiasis
Official title Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
ClinicalTrials.gov ID: NCT06852937
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
- ASA physical status classification 1-2 and adequate organ function
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- With informed consent
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.