18 and older, any sex, with Abdominal Injury or Thoracic Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.Primary· 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 imp
Group
Value
95% CI
Abdominal
0
Thoracic
9
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.Primary· 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. Result
Group
Value
95% CI
Overall
9
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
2
Thoracic
2
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
44
Thoracic
55
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
0
Thoracic
0
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
3
Thoracic
42
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
0
Thoracic
5
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
0
Thoracic
7
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
0
Thoracic
3
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
1
Thoracic
8
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
0
Thoracic
2
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.Secondary· Up to and including 30 (+14) days post-operative.
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.
Group
Value
95% CI
Abdominal
1
Thoracic
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected up to and including 30 (+14) days post-procedure..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medtronic - MITG
Last refreshed: 10 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03515811.