- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816671
MicroCutter Assisted Thoracic Surgery Hemostasis Registry (MATCH)
September 7, 2018 updated by: AesDex, LLC
The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures.
Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases.
Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.
Study Overview
Detailed Description
The MATCH registry is a prospective, open label, multi-center observational registry with enrollment of patients requiring surgical stapling during a lobectomy or segmentectomy.
Patients will be treated per the clinicians standard of care with medical history and demographic data collected pre-procedure, operative data including clinician's objective and subjective evaluation of the stapler and confirmation of any complications via query and data collection at hospital discharge and each clinician's standard post-operative contact.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Middlesbrough, United Kingdom
- James Cook University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients scheduled for thoracic surgical procedures requiring the use of a surgical stapler.
Description
Inclusion Criteria:
- Patients undergoing lobectomy/segmentectomy in which the MicroCutter Stapler and Reloads were used.
- Patient is willing and able to sign informed consent form to participate in registry, allowing for collection of data.
Exclusion Criteria:
- Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemostasis of vessel staple line
Time Frame: through study completion, approximately 1 month
|
Objective classification of hemostasis achieved by the MicroCutter Stapler used on label using a Likert like scale; from 1 (no bleeding) to 5 (bleeding requiring conversion to open procedure or discovered post operatively)
|
through study completion, approximately 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shanda Blackmon, MD, Mayo Clinic
- Principal Investigator: Joel Dunning, PhD, James Cook University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
November 30, 2017
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
June 23, 2016
First Submitted That Met QC Criteria
June 24, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Actual)
September 10, 2018
Last Update Submitted That Met QC Criteria
September 7, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CP-2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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