Abdominal InjuryNCT03515811
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
An observational study of Abdominal Injury and Thoracic Diseases, run by Medtronic - MITG at 11 sites in 5 countries.
Trial summary
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Injury, Thoracic Diseases
- What is being tested?
- Signia™ Stapling System
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 22 Jan 2019to 13 Jul 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 74 Thoracic subjects arm 53 abdominal subjects arm
Who may be able to join
- Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
- The subject is scheduled to undergo an indicated primary abdominal or thoracic procedure for resection, transection and creation of anastomosis per the IFU where the Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate for the procedure only Medtronic buttresses can be used during the course of the study.
- 3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
- 3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).
Who cannot join
- Subjects undergoing cardiac and vascular procedures.
- The procedure is an emergency procedure.
- The procedure is a revision/reoperation of a primary operation..
- Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
- Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
- The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
Show all 10Show fewer
- The subject has comorbidities which, in the clinical judgment 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 another investigational drug or device research study or has been enrolled in another study within 30 days of enrollment.
- Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States6 sites
Albany Medical College
Albany, New York, 12208
WakeMed Bariatric Specialists of North Carolina
Cary, North Carolina, 27518
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Duke Regional Hospital
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Cedars Sinai Medical Center
Los Angeles, California, 90048
Spain2 sites
Hospital Universitario del Rocio
Seville, 41009
Hospital Universitario Virgen Macarena
Seville, 41009
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V4G5
About this study
Official title: To Confirm the Safety and Performance of the Signia™ Stapling System Using Signia™ Intelligent Loading Units With Tri-Staple™ 2.0 Intelligent Reloads in Abdominal and Thoracic Procedures.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
Read the detailed description
This study will evaluate the use of Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads in indicated abdominal or thoracic procedures (e.g., resection, transection of tissue, and creation of anastomoses). Subjects who meet the eligibility criteria will be considered for study participation at a minimum of 10 sites and will be followed up to and including 30 days post-operative. Overall the study is estimated to progress for up to 24 months.
- Conditions
- Abdominal Injury, Thoracic Diseases
- Being tested
- Signia™ Stapling System
- Medical subject headings
- Abdominal Injuries, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signia™ Stapling SystemDevice
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal | Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects). Receives: Device: Signia™ Stapling System | |
| Thoracic | Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects). Receives: Device: Signia™ Stapling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria:
Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in:
- Resulted in a life-threatening illness or injury, or
- Resulted in a permanent impairment of a body structure or a body function, or
- In-patient or prolonged hospitalization, or
- Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Measured: Up to and including 30 days intra- and post-operative.
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria:
Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in:
- Resulted in a life-threatening illness or injury, or
- Resulted in a permanent impairment of a body structure or a body function, or
- In-patient or prolonged hospitalization, or
- Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Measured: Up to and including 30 (+14) days post-procedure.
Secondary outcomes (10)
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.
The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.
Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as > 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered >7 days in duration.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.
Measured: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.
The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.
Measured: Up to and including 30 (+14) days post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start22 Jan 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
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 Abdominal InjuryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelley Kennedy, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515811
- Sponsor's protocol ID
- MDT17025SIG
- Status last verified
- May 2024
- First submitted
- 23 Apr 2018
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Confirm the Safety and Performance of the Signia™ Stapling System Using Signia™ Intelligent Loading Units With Tri-Staple™ 2.0 Intelligent Reloads in Abdominal and Thoracic Procedures.
- ClinicalTrials.gov ID
- NCT03515811
- Acronym / sponsor ID
- MDT17025SIG
- Conditions
- Abdominal Injury, Thoracic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
Detailed description
This study will evaluate the use of Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads in indicated abdominal or thoracic procedures (e.g., resection, transection of tissue, and creation of anastomoses). Subjects who meet the eligibility criteria will be considered for study participation at a minimum of 10 sites and will be followed up to and including 30 days post-operative. Overall the study is estimated to progress for up to 24 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal | – | Device: Signia™ Stapling SystemSignia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). |
| Thoracic | – | Device: Signia™ Stapling SystemSignia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 74 Thoracic subjects arm 53 abdominal subjects arm
Key inclusion criteria (5 listed)
- Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
- The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
- The subject is scheduled to undergo an indicated primary abdominal or thoracic procedure for resection, transection and creation of anastomosis per the IFU where the Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate for the procedure only Medtronic buttresses can be used during the course of the study.
- 3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
- 3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).
Key exclusion criteria (10 listed)
- Subjects undergoing cardiac and vascular procedures.
- The procedure is an emergency procedure.
- The procedure is a revision/reoperation of a primary operation..
- Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
- 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 |
|---|---|---|
| Signia™ Stapling SystemSignia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads. | Device | Abdominal, Thoracic |
Primary outcome
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
Time frame: Up to and including 30 days intra- and post-operative.
The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
Time frame: Up to and including 30 (+14) days post-procedure.
The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: 1. Resulted in a life-threatening illness or injury, or 2. Resulted in a permanent impairment of a body structure or a body function, or 3. In-patient or prolonged hospitalization, or 4. Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
10 secondary outcomes
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
Time frame: Up to and including 30 (+14) days post-operative.
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.
Time frame: Up to and including 30 (+14) days post-operative.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Kelley Kennedy study director
Medtronic
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Injury and Thoracic Diseases, run by Medtronic - MITG at 11 sites in 5 countries.
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 5 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Spain, Canada, Italy, 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 31 Mar 2023). 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 Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks. (time frame: Up to and including 30 days intra- and post-operative.). The study lists 2 primary outcomes in all. 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 May 2024.