NCT01855308

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

5 years

First QC Date

May 9, 2013

Last Update Submit

September 22, 2017

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • Completion of procedure by SSRC

    At time of surgery

Secondary Outcomes (1)

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

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

Study Arms (1)

Single site robotic chole

Cholecystectomy performed through a single incision with the robot.

Procedure: Single site robotic choleDevice: da Vinci Si Surgical System

Interventions

Single site robotic cholePROCEDURE

Cholecystectomy

Single site robotic chole
da Vinci Si Surgical SystemDEVICE

minimally invasive robotic surgical system designed to facilitate complex procedures

Single site robotic chole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • presence of symptomatic gallstones

You may not qualify if:

  • significant previous open abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Mohamed R Ali, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 16, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

US(1)