Non-emergent, Abdominal or Thoracic ProceduresNCT02500537
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
A study testing Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in people with Non-emergent, Abdominal or Thoracic Procedures, run by Medtronic - MITG at 1 site in United Kingdom.
Trial summary
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-emergent, Abdominal or Thoracic Procedures
- What is being tested?
- Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be 18-80 years of age
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
- The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)
- Thoracic procedures may include, but are not limited to, wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
- Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
- For thoracic subjects: the subject has a FEV1 ≥40%
Who cannot join
- Subjects undergoing cardiac and vascular procedures
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- Any female subject who is pregnant
- Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
- Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
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- The subject is unable or unwilling to comply with the study requirements or follow-up schedule
- The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
- The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
- The subject is concurrently enrolled in an investigational drug or device research study
Trial locations and contacts
1 site in 1 country.
About this study
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
Read the detailed description
The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.
- Being tested
- Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo GIA™ Reinforced Reload with Tri-Staple™ TechnologyDevice
Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Procedures | Experimental | Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology Receives: Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology |
| Thoracic Procedures | Experimental | Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology Receives: Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
Measured: Through 30 Days
Secondary outcomes (7)
Staple Line Assessment: Incidence of Staple Line Bleeding
The incidence of staple line bleeding will be measured as ≥ 50 cc
Measured: Day 0
Staple Line Assessment: Incidence of Leakage
As measured by air leak test, or standard of care, as applicable
Measured: Day 0
Staple Line Assessment: Duration of Leakage, Post-Op
Duration of leakage based on chest tube drainage in days
Measured: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Leakage; Post-Op
The incidence of leakage for abdominal procedures; Post-up
Measured: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Post-operative Infection
Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients
Measured: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment:
Number of additional intervention(s) to treat staple-line failure
Measured: Participants will be followed for the duration of hospital stay, on average up to 5 days post-op
Incidence of Repeat Hospital Admissions for Procedural-related Complications
Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure
Measured: 30 Days following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-emergent, Abdominal or Thoracic ProceduresStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Ahmed, PhD, FRCS, Principal investigator, St Mary's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500537
- Sponsor's protocol ID
- COVRRBT0451
- Status last verified
- Feb 2017
- First submitted
- 1 Jun 2015
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
- ClinicalTrials.gov ID
- NCT02500537
- Acronym / sponsor ID
- COVRRBT0451
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
Detailed description
The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Procedures | Experimental | Device: Endo GIA™ Reinforced Reload with Tri-Staple™ TechnologyAbdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection. Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology |
| Thoracic Procedures | Experimental | Device: Endo GIA™ Reinforced Reload with Tri-Staple™ TechnologyThoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures. Device: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject must be 18-80 years of age
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
- The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)
- For thoracic subjects: the subject has a FEV1 ≥40%
Key exclusion criteria (10 listed)
- Subjects undergoing cardiac and vascular procedures
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- Any female subject who is pregnant
- Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
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 |
|---|---|---|
| Endo GIA™ Reinforced Reload with Tri-Staple™ TechnologyEndo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) | Device | Abdominal Procedures, Thoracic Procedures |
Primary outcome
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.
Time frame: Through 30 Days
7 secondary outcomes
Staple Line Assessment: Incidence of Staple Line Bleeding
Time frame: Day 0
Staple Line Assessment: Incidence of Leakage
Time frame: Day 0
Staple Line Assessment: Duration of Leakage, Post-Op
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Leakage; Post-Op
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment: Incidence of Post-operative Infection
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days
Staple Line Assessment:
Time frame: Participants will be followed for the duration of hospital stay, on average up to 5 days post-op
Incidence of Repeat Hospital Admissions for Procedural-related Complications
Time frame: 30 Days following procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Ahmed Ahmed, PhD, FRCS principal investigator
St Mary's Hospital, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in people with Non-emergent, Abdominal or Thoracic Procedures, run by Medtronic - MITG 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 4 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. (time frame: Through 30 Days). 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 4 Apr 2017.