Simulation for Preparation of Robotic SurgeryNCT02267551
Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
A study testing Mimic dv-Trainer and daVinci Skills Simulator in people with Simulation for Preparation of Robotic Surgery, run by Atlantic Health System at 1 site in United States.
Trial summary
The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation for Preparation of Robotic Surgery
- What is being tested?
- Mimic dv-Trainer and daVinci Skills Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training
- Completion of the online orientation to daVinci Surgical System
Who cannot join
- Performance of any robotic surgical procedures as the console surgeon
- Performance of any robotic simulator protocols
- Any significant amount of time spent on a virtual reality robotic simulator
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Medical Center
Morristown, New Jersey, 07960
About this study
The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.
- Being tested
- Mimic dv-Trainer, daVinci Skills Simulator
- Keywords
- robotic surgery, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mimic dv-TrainerOther
daVinci Skills SimulatorOther
| Study group | Role | What they receive |
|---|---|---|
| Mimic dV-Trainer | Other | Not described Receives: Other: Mimic dv-Trainer |
| daVinci Skills Simulator | Other | Not described Receives: Other: daVinci Skills Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os.
Measured: at time of supracervical hysterectomy
Secondary outcomes (3)
Estimated Blood Loss
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
Measured: during the surgical procedure
Surgical Skill Rating
As measured by the global assessment tool for evaluation of intraoperative laparoscopic skills (GOALS) tool via video assessment. These ratings will be performed by a group of surgeons who are not involved in the study and are masked as to the identity of the study surgeons.
Measured: following completion of the procedure
Continued success with robotic surgery after participation in the study
The number of cases each participating resident performs as primary surgeon the 12 months after completion of the study will be recorded
Measured: during the 12 months following surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation for Preparation of Robotic SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267551
- Sponsor's protocol ID
- 574541-1
- Status last verified
- May 2016
- First submitted
- 14 Oct 2014
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):48-51. doi: 10.1097/SPV.0000000000000045.
PubMed 24368489
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
- ClinicalTrials.gov ID
- NCT02267551
- Acronym / sponsor ID
- 574541-1
- Keywords
- robotic surgery, simulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Oct 2014 (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.
The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mimic dV-Trainer | Other | Other: Mimic dv-Trainer |
| daVinci Skills Simulator | Other | Other: daVinci Skills Simulator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training
- Completion of the online orientation to daVinci Surgical System
Key exclusion criteria (3 listed)
- Performance of any robotic surgical procedures as the console surgeon
- Performance of any robotic simulator protocols
- Any significant amount of time spent on a virtual reality robotic simulator
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 |
|---|---|---|
| Mimic dv-Trainer | Other | Mimic dV-Trainer |
| daVinci Skills Simulator | Other | daVinci Skills Simulator |
Primary outcome
Operative Time
Time frame: at time of supracervical hysterectomy
Operative time will be measured by time elapsed between first grasp of the uterine fundus with the robotic single tooth tenaculum until amputation of the specimen at the internal cervical os.
3 secondary outcomes
Estimated Blood Loss
Time frame: during the surgical procedure
Surgical Skill Rating
Time frame: following completion of the procedure
Continued success with robotic surgery after participation in the study
Time frame: during the 12 months following surgical procedure
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Background: PubMed 24368489Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):48-51. doi: 10.1097/SPV.0000000000000045.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mimic dv-Trainer and daVinci Skills Simulator in people with Simulation for Preparation of Robotic Surgery, run by Atlantic Health System 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 May 2016. 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
Operative Time (time frame: at time of supracervical hysterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267551, which also lists 1 linked publication.
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 6 May 2016.