NCT02816671

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

June 23, 2016

Last Update Submit

September 7, 2018

Conditions

LobectomySegmentectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Surgical StaplerDEVICE

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

Also known as: MicroCutter Stapler and Reloads

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for thoracic surgical procedures requiring the use of a surgical stapler.

You may qualify if:

  • 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.

You may not qualify if:

  • Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Cook University Hospital

Middlesbrough, United Kingdom

Location

MeSH Terms

Interventions

Surgical Staplers

Intervention Hierarchy (Ancestors)

Surgical InstrumentsSurgical EquipmentEquipment and Supplies

Study Officials

  • Shanda Blackmon, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Joel Dunning, PhD

    James Cook University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 28, 2016

Study Start

June 1, 2016

Primary Completion

November 30, 2017

Study Completion

September 1, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)