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NCT01855308 Clinical Trial

Single Site Robotic Cholecystectomy in Non Selected Patients

Cholelithiasis Clinical Trial

— SSRC  

Official title:
Single Site Robotic Cholecystectomy in Non Selected Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01855308
Other study ID # 307021
Secondary ID 307021
Status Completed
Phase N/A
First received May 9, 2013
Last updated September 22, 2017
Start date January 2012
Est. completion date January 2017

Study information
Verified date September 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a study of new technology to allow gallbladder removal through a single small surgical incision. A surgical robot is utilized to help navigate the small space. In this study, patient characteristics are broad to assess how applicable the procedure is to everyone.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- presence of symptomatic gallstones

Exclusion Criteria:

- significant previous open abdominal surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Single site robotic chole
Cholecystectomy
Device:
• da Vinci Si Surgical System
minimally invasive robotic surgical system designed to facilitate complex procedures

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of procedure by SSRC At time of surgery
Secondary Adverse events to study participants (e.g. bile duct injury, hemorrhage) At time of procedure and in clinic up to 30 days after surgery
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