Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
ADOPT
A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
1 other identifier
observational
10
1 country
1
Brief Summary
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2014
1 active site
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
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 26, 2016
July 1, 2016
1.8 years
August 21, 2014
July 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of complications during independent cases post proctorship
collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair
up to 30 days
Eligibility Criteria
Determined by surgeon
You may qualify if:
- Determined by surgeon's standard of care
You may not qualify if:
- Determined by surgeon's standard of care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Pearl
University of Maryland
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2014
First Posted
September 12, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07