Trial Outcomes & Findings for A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System. (NCT NCT03515811)
NCT ID: NCT03515811
Last Updated: 2024-05-10
Results Overview
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.
COMPLETED
136 participants
Up to and including 30 days intra- and post-operative.
2024-05-10
Participant Flow
Participant milestones
| Measure |
Abdominal
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Thoracic
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
85
|
|
Overall Study
COMPLETED
|
46
|
77
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Abdominal
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Thoracic
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Technical Problems
|
1
|
0
|
|
Overall Study
Subject Unable to Return for Follow-Up
|
0
|
2
|
|
Overall Study
COVID-19
|
0
|
1
|
Baseline Characteristics
Pregnancy test was only performed for female subjects of child-bearing age and potential.
Baseline characteristics by cohort
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 13.25 • n=51 Participants
|
68.0 years
STANDARD_DEVIATION 10.16 • n=85 Participants
|
62.5 years
STANDARD_DEVIATION 14.23 • n=136 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=51 Participants
|
35 Participants
n=85 Participants
|
75 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=51 Participants
|
50 Participants
n=85 Participants
|
61 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=51 Participants
|
5 Participants
n=85 Participants
|
19 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=51 Participants
|
49 Participants
n=85 Participants
|
86 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
31 Participants
n=85 Participants
|
31 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
2 Participants
n=85 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=51 Participants
|
4 Participants
n=85 Participants
|
15 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=51 Participants
|
79 Participants
n=85 Participants
|
117 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=51 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=51 Participants
|
5 participants
n=85 Participants
|
5 participants
n=136 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=51 Participants
|
38 participants
n=85 Participants
|
76 participants
n=136 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=51 Participants
|
18 participants
n=85 Participants
|
18 participants
n=136 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=51 Participants
|
13 participants
n=85 Participants
|
13 participants
n=136 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=51 Participants
|
11 participants
n=85 Participants
|
24 participants
n=136 Participants
|
|
Pregnancy Test Performed
|
20 Participants
n=40 Participants • Pregnancy test was only performed for female subjects of child-bearing age and potential.
|
7 Participants
n=35 Participants • Pregnancy test was only performed for female subjects of child-bearing age and potential.
|
27 Participants
n=75 Participants • Pregnancy test was only performed for female subjects of child-bearing age and potential.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=136 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to and including 30 (+14) days post-operative.Population: 36 subjects had intra-operative assessment data incorrectly recorded for B-formation, so this data was excluded from this part of the intra-operative analysis results. Thus, the overall number of participants analyzed is different for this parameter (44 for abdominal, and 56 for thoracic).
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.
Outcome measures
| Measure |
Abdominal
n=44 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=56 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).
|
44 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Up to and including 30 (+14) days post-operative.Population: One abdominal subject died during their study procedure, so the Overall Number of Participants Analyzed in the Abdominal group dropped from 51 to 50 for the intra-operative assessments, since their staple-line was not assessed.
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.
Outcome measures
| Measure |
Abdominal
n=50 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
|
3 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Up to and including 30 (+14) days post-operative.Population: One abdominal subject died during their study procedure, so the Overall Number of Participants Analyzed in the Abdominal group dropped from 51 to 50 for the intra-operative assessments, since their staple-line was not assessed.
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.
Outcome measures
| Measure |
Abdominal
n=50 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to and including 30 (+14) days post-operative.Population: Duration of air leakage was not assessed in the abdominal group, becasue there were no air leaks in the abdominal group.
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.
Outcome measures
| Measure |
Abdominal
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal
n=51 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (0.0%-7.0%)
|
Thoracic
n=85 Participants
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
95% Confidence Interval: (5.0%-19.2%).
|
|---|---|---|
|
The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.
|
1 Participants
|
4 Participants
|
Adverse Events
Abdominal
Thoracic
Serious adverse events
| Measure |
Abdominal
n=51 participants at risk
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Thoracic
n=85 participants at risk
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Vascular disorders
Arterial haemorrhage
|
2.0%
1/51 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
0.00%
0/85 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Injury, poisoning and procedural complications
Bronchial injury
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Product Issues
Device leakage
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
9.4%
8/85 • Number of events 8 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
Other adverse events
| Measure |
Abdominal
n=51 participants at risk
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Abdominal (approximately 53 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
Thoracic
n=85 participants at risk
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.
Thoracic (approximately 74 subjects).
Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
17.6%
15/85 • Number of events 15 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
10.6%
9/85 • Number of events 9 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
|
Surgical and medical procedures
Post-operative leak
|
0.00%
0/51 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
8.2%
7/85 • Number of events 10 • Adverse events were collected up to and including 30 (+14) days post-procedure.
|
Additional Information
Andrea DiScipio, Senior Clinical Research Specialist
Medtronic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place