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.
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 Type
OBSERVATIONAL
Enrollment
136
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
Cedars Sinai Medical Center
Los Angeles, California, United States
Albany Medical College
Albany, New York, United States
WakeMed Bariatric Specialists of North Carolina
Cary, North Carolina, United States
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: 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.
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), 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: 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.
Time frame: Up to and including 30 (+14) days post-procedure.
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UNC Chapel Hill
Chapel Hill, North Carolina, United States
Duke Regional Hospital
Durham, North Carolina, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Azienda Ospedaleria San Gerardo
Monza, Italy
Hospital Universitario del Rocio
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
...and 1 more locations
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Up to and including 30 (+14) days post-operative.