CholelithiasisSSRCNCT01855308
Single Site Robotic Cholecystectomy in Non Selected Patients
An observational study of Cholelithiasis, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Single site robotic chole and da Vinci Si Surgical System
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- presence of symptomatic gallstones
Who cannot join
- significant previous open abdominal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
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.
- Conditions
- Cholelithiasis
- Being tested
- Single site robotic chole, da Vinci Si Surgical System
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single site robotic choleProcedure or surgery
Cholecystectomy
da Vinci Si Surgical SystemDevice
minimally invasive robotic surgical system designed to facilitate complex procedures
| Study group | Role | What they receive |
|---|---|---|
| Single site robotic chole | Cholecystectomy performed through a single incision with the robot. Receives: Procedure: Single site robotic chole; Device: da Vinci Si Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of procedure by SSRC
Measured: At time of surgery
Secondary outcomes (1)
Adverse events to study participants (e.g. bile duct injury, hemorrhage)
Measured: At time of procedure and in clinic up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R Ali, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855308
- Sponsor's protocol ID
- 307021
- Other IDs
- 307021
- Acronym
- SSRC
- Status last verified
- Sep 2017
- First submitted
- 9 May 2013
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Site Robotic Cholecystectomy in Non Selected Patients
- ClinicalTrials.gov ID
- NCT01855308
- Acronym / sponsor ID
- SSRC / 307021
- Conditions
- Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single site robotic chole | – | Procedure: Single site robotic chole, Device: da Vinci Si Surgical SystemCholecystectomy performed through a single incision with the robot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- presence of symptomatic gallstones
Key exclusion criteria (1 listed)
- significant previous open abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single site robotic choleCholecystectomy | Procedure or surgery | Single site robotic chole |
| da Vinci Si Surgical Systemminimally invasive robotic surgical system designed to facilitate complex procedures | Device | Single site robotic chole |
Primary outcome
Completion of procedure by SSRC
Time frame: At time of surgery
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed R Ali, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of procedure by SSRC (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.