MicroCutter Assisted Thoracic Surgery Hemostasis Registry

NCT ID: NCT02816671

Last Updated: 2018-09-10

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

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lobectomy Segmentectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Surgical Stapler

Patients in whom the MicroCutter stapler was used during a thoracic surgical procedure.

Intervention Type DEVICE

Other Intervention Names

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MicroCutter Stapler and Reloads

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AesDex, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shanda Blackmon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Joel Dunning, PhD

Role: PRINCIPAL_INVESTIGATOR

James Cook University Hospital

Locations

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James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CP-2016-01

Identifier Type: -

Identifier Source: org_study_id

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