MicroCutter Assisted Thoracic Surgery Hemostasis Registry

• Conditions: Segmentectomy; Lobectomy

• Registration Number: NCT02816671
• Lead Sponsor: AesDex, LLC

Brief Summary

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

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2017-11-30
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemostasis of vessel staple line	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)

Trial Locations

Locations (1)

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom