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Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Weichieh Tsai
jill.hataka@gmail.com
886-978226836
Backup
Jacqueline Liang
jacqueline.liang@intusurg.com
886-914255380
Time Frame
Start Date: 2024-12-21
Estimated Completion Date: 2026-12
Participants
Target number of participants: 25
Treatments
Experimental: Operation of focus procedure with da Vinci SP Surgery System
Operation of cholecystectomy and common bile duct exploration with da Vinci SP Surgery System
Sponsors
Leads: National Taiwan University Hospital
Collaborators: Intuitive Surgical

This content was sourced from clinicaltrials.gov