Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery

NCT ID: NCT02267551

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Simulation for Preparation of Robotic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mimic dV-Trainer

Group Type OTHER

Mimic dv-Trainer

Intervention Type OTHER

daVinci Skills Simulator

Group Type OTHER

daVinci Skills Simulator

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mimic dv-Trainer

Intervention Type OTHER

daVinci Skills Simulator

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24368489 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

574541-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EMG-Based Hand-Wrist Control: Study B Mirrored
NCT04692571 COMPLETED EARLY_PHASE1