Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

NCT06852937 | Recruiting FDA Device

• 1 other identifier: 202409006DIPD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Cholelithiasis; Choledocholithiasis

Outcome Measures

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.

  During Surgery

Secondary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  up to 6 months

Study Arms (1)

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

Device: da Vinci SP Surgery System

Interventions

da Vinci SP Surgery System DEVICE

da Vinci SP Surgery System

Operation of focus procedure with da Vinci SP Surgery System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Intuitive Surgical: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Choledocholithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Study Officials

• Yao-Ming Wu

  Vice Superintendent of NTUCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weichieh Tsai

CONTACT

886-978226836; jill.hataka@gmail.com

Jacqueline Liang

CONTACT

886-914255380; jacqueline.liang@intusurg.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 28, 2025
• Study Start: December 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)