LobectomyMATCHNCT02816671
MicroCutter Assisted Thoracic Surgery Hemostasis Registry
An observational study of Lobectomy and Segmentectomy, run by AesDex, LLC at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lobectomy, Segmentectomy
- What is being tested?
- Surgical Stapler
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Sep 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled for thoracic surgical procedures requiring the use of a surgical stapler.
Who may be able to join
- 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.
Who cannot join
- Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lobectomy, Segmentectomy
- Being tested
- Surgical Stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical StaplerDevice
Also called MicroCutter Stapler and Reloads
Patients in whom the MicroCutter stapler was used during a thoracic surgical procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion30 Nov 2017
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LobectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- AesDex, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanda Blackmon, MD, Principal investigator, Mayo ClinicJoel Dunning, PhD, Principal investigator, James Cook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816671
- Sponsor's protocol ID
- CP-2016-01
- Acronym
- MATCH
- Status last verified
- Sep 2018
- First submitted
- 23 Jun 2016
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroCutter Assisted Thoracic Surgery Hemostasis Registry
- ClinicalTrials.gov ID
- NCT02816671
- Acronym / sponsor ID
- MATCH / CP-2016-01
- Conditions
- Lobectomy, Segmentectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AesDex, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for thoracic surgical procedures requiring the use of a surgical stapler.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical StaplerAlso: MicroCutter Stapler and ReloadsPatients in whom the MicroCutter stapler was used during a thoracic surgical procedure. | Device | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Lobectomy
Not yet recruitingObservational study
Preoperative Nutritional Status and Postoperative Outcomes in Geriatric Lung Resection
Thoracotomy, Toracosurgery
Not yet recruiting
Postoperative Pulmonary Function Assessment Based on Deep Learning Study
Lung Cancer (NSCLC)
Recruiting
Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery
Thoracic Surgical Procedures
Not yet recruiting
STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection
Thyroid Gland Medullary Carcinoma
Active, not recruiting
Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)
Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanda Blackmon, MD principal investigator
Mayo Clinic
Joel Dunning, PhD principal investigator
James Cook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lobectomy and Segmentectomy, run by AesDex, LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis of vessel staple line (time frame: through study completion, approximately 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.