MicroCutter Assisted Thoracic Surgery Hemostasis Registry

Lobectomy Clinical Trial

— MATCH  

Official title:

MicroCutter Assisted Thoracic Surgery Hemostasis Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02816671
• Other study ID #: CP-2016-01
• Status: Active, not recruiting
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: AesDex, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lobectomy
• Segmentectomy

Intervention

Device:
• Surgical Stapler
Patients in whom the MicroCutter stapler was used during a thoracic surgical procedure.

Locations

Country	Name	City	State
United Kingdom	James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
AesDex, LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis of vessel staple line	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