Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Conditions
Brief summary
The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.
Interventions
N/A observational registry
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements * Patient has, or is intended to receive or be treated with, an eligible Medtronic product * Patient is consented within the enrollment window of the therapy received, as applicable
Exclusion criteria
* Patient who is, or is expected to be, inaccessible for follow-up * Patient is excluded by local law * Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Hemostatic Intervention | During Procedure | * Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins. * Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins. * Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale | During Procedure | The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon). |
| Intraoperative Assessments: Incidence of Staple Line Bleeding | During Procedure | Number of firings that had an incidence of staple line bleeding of \>50cc |
| Incidence of Repeat Hospital Admission for Primary Procedure-related Complications | 30 days | — |
| Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure | 30 days | Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other) |
| Device Deficiencies | 30-days | incidence of subjects reporting device deficiencies affecting the intended performance of the device up to and including 30 days following the use of device (i.e. Signia™ Small Diameter Reloads) in surgery |
| Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure | During Procedure | Additional interoperative interventions to treat staple line failure (applying additional stapler reloads, applying compression greater than what is considered typical, over-sewing with suture, placing clips, use of energy, use of seatbelt, other) |
Countries
United States
Participant flow
Recruitment details
Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for the transection of vasculature or thin tissue meeting the cohort criteria were considered for this study.
Pre-assignment details
This study was conducted in accordance with each site's standard of care. Assignment to one of the three study groups was dependent on the anatomical location where Signia SDR was used and was not randomly assigned.
Participants by arm
| Arm | Count |
|---|---|
| Thoracic Adult Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients. | 123 |
| Abdominal Adult Use of Signia SDR for the transection of renal arteries and veins in adult patients. | 163 |
| Abdominal Pediatric Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients. | 95 |
| Total | 381 |
Baseline characteristics
| Characteristic | Thoracic Adult | Total | Abdominal Pediatric | Abdominal Adult |
|---|---|---|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 12.1 | 44.9 Years STANDARD_DEVIATION 23.7 | 11.3 Years STANDARD_DEVIATION 3.8 | 48.4 Years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 67 Participants | 42 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 292 Participants | 53 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 22 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 44 Participants | 10 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 66 Participants | 33 Participants | 27 Participants |
| Race (NIH/OMB) White | 107 Participants | 256 Participants | 49 Participants | 100 Participants |
| Region of Enrollment United States | 123 Participants | 381 Participants | 95 Participants | 163 Participants |
| Sex: Female, Male Female | 66 Participants | 192 Participants | 31 Participants | 95 Participants |
| Sex: Female, Male Male | 57 Participants | 189 Participants | 64 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 163 | 0 / 95 |
| other Total, other adverse events | 6 / 123 | 6 / 163 | 8 / 95 |
| serious Total, serious adverse events | 43 / 123 | 7 / 163 | 4 / 95 |
Outcome results
Primary
Incidence of Intraoperative Hemostatic Intervention
* Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins. * Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins. * Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).
Time frame: During Procedure
Population: Analysis was conducted on the number of firings of the Signia SDR device. Study participants could have 1 or more firings.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Thoracic Adult | Incidence of Intraoperative Hemostatic Intervention | 3 Firings |
| Abdominal Adult | Incidence of Intraoperative Hemostatic Intervention | 2 Firings |
| Abdominal Pediatric | Incidence of Intraoperative Hemostatic Intervention | 0 Firings |
Secondary
Device Deficiencies
incidence of subjects reporting device deficiencies affecting the intended performance of the device up to and including 30 days following the use of device (i.e. Signia™ Small Diameter Reloads) in surgery
Time frame: 30-days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Adult | Device Deficiencies | 0 Participants |
| Abdominal Adult | Device Deficiencies | 1 Participants |
| Abdominal Pediatric | Device Deficiencies | 0 Participants |
Secondary
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Adult | Incidence of Repeat Hospital Admission for Primary Procedure-related Complications | 1 Participants |
| Abdominal Adult | Incidence of Repeat Hospital Admission for Primary Procedure-related Complications | 1 Participants |
| Abdominal Pediatric | Incidence of Repeat Hospital Admission for Primary Procedure-related Complications | 0 Participants |
Secondary
Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure
Additional interoperative interventions to treat staple line failure (applying additional stapler reloads, applying compression greater than what is considered typical, over-sewing with suture, placing clips, use of energy, use of seatbelt, other)
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Adult | Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure | 3 Participants |
| Abdominal Adult | Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure | 1 Participants |
| Abdominal Pediatric | Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure | 0 Participants |
Secondary
Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale
The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon).
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Adult | Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale | 117 Participants |
| Abdominal Adult | Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale | 156 Participants |
| Abdominal Pediatric | Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale | 95 Participants |
Secondary
Intraoperative Assessments: Incidence of Staple Line Bleeding
Number of firings that had an incidence of staple line bleeding of \>50cc
Time frame: During Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Thoracic Adult | Intraoperative Assessments: Incidence of Staple Line Bleeding | 0 Firings |
| Abdominal Adult | Intraoperative Assessments: Incidence of Staple Line Bleeding | 0 Firings |
| Abdominal Pediatric | Intraoperative Assessments: Incidence of Staple Line Bleeding | 0 Firings |
Secondary
Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure
Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Adult | Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure | 0 Participants |
| Abdominal Adult | Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure | 0 Participants |
| Abdominal Pediatric | Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure | 0 Participants |