CClinicalTrials.gg
CompletedNCT01855308SSRCUpdated Sep 26, 2017

Single Site Robotic Cholecystectomy in Non Selected Patients

An observational study in Cholelithiasis, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-26.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 160 is below the median of 200 across 83 observational studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who are referred to the surgery program with non-emergency gallbladder disease, for which cholecystectomy is indicated, will be given the opportunity to participate. Referred patients typically come from the primary care setting. The demographic composition of the study population will depend in the patient referred to the program.

Inclusion criteria

  • presence of symptomatic gallstones

Exclusion criteria

Exclusion Criteria:

  • significant previous open abdominal surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No

Groups and cohorts

  • Single site robotic chole

    Cholecystectomy performed through a single incision with the robot.

    Procedure: Single site robotic chole · Device: da Vinci Si Surgical System

Interventions

  • ProcedureSingle site robotic chole

    Cholecystectomy

  • Deviceda Vinci Si Surgical System

    minimally invasive robotic surgical system designed to facilitate complex procedures

06

What researchers measure

Primary outcomes

  1. Completion of procedure by SSRC

    Time frame: At time of surgery

Secondary outcomes

  1. Adverse events to study participants (e.g. bile duct injury, hemorrhage)

    Time frame: At time of procedure and in clinic up to 30 days after surgery

07

Study locations

1 site
  • UC Davis Medical Center
    Sacramento, California 95817, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01855308
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
May 16, 2013
Start date
Jan 2012
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Sep 26, 2017

Study contacts

Mohamed R Ali, MD
principal investigator · UC Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion