N/A
N=136
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
Abdominal Injury · Thoracic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03515811 ↗Enrolled (actual)
136
Serious AEs
19.9%
Results posted
Mar 2023
Primary outcome: Primary: The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks. — 0; 9 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Signia™ Stapling System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks. |
9 | — |
| PRIMARY The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks. |
9 | — |
| SECONDARY The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device. |
2; 2 | — |
| SECONDARY The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation). |
44; 55 | — |
| SECONDARY The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences. |
0; 0 | — |
| SECONDARY The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure. |
3; 42 | — |
| SECONDARY The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage. |
0; 5 | — |
| SECONDARY The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage. |
0; 7 | — |
| SECONDARY The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days. |
0; 3 | — |
| SECONDARY The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection. |
1; 8 | — |
| SECONDARY The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure. |
0; 2 | — |
| SECONDARY The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications. |
1; 4 | — |
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 Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03515811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.