N/A
Completed N=381
Medtronic Signia SDR Product Surveillance Registry
Minimally Invasive Surgical Procedures · Surgical Procedures, Operative
Source: ClinicalTrials.gov NCT05095935 ↗
Enrolled (actual)
381
Serious AEs
14.2%
Results posted
Jan 2026
Primary outcomePrimary: Incidence of Intraoperative Hemostatic Intervention — 3; 2; 0 Firings
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Intraoperative Hemostatic Intervention |
3; 2; 0 | — |
| SECONDARY Incidence of Repeat Hospital Admission for Primary Procedure-related Complications |
1; 1; 0 | — |
| SECONDARY Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale |
117; 156; 95 | — |
| SECONDARY Intraoperative Assessments: Incidence of Staple Line Bleeding |
0; 0; 0 | — |
| SECONDARY Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure |
3; 1; 0 | — |
| SECONDARY Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure |
0; 0; 0 | — |
| SECONDARY Device Deficiencies |
0; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05095935). 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. Informational only — not medical advice.