Clinical trial NCT05095935: Medtronic Signia SDR Product Surveillance Registry
Official title: Medtronic Signia Small Diameter Reload Product Surveillance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Invasive Surgical Procedures
Surgical Procedures, Operative
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for transection of the arteries and veins meeting the cohort criteria.

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.


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

Primary outcomes:
measure: Incidence of intraoperative hemostatic intervention
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of repeat hospital admission for primary procedure-related complications
timeFrame: 30 days
measure: Intraoperative assessments: Assessment of staple line integrity using a five-point Likert scale
timeFrame: 30 days
measure: Intraoperative assessments: Incidence of staple line bleeding (measured as > 50cc)
timeFrame: 30 days
measure: Intraoperative assessments: Additional intervention(s) to treat staple line failure
timeFrame: 30 days
measure: Post-operative assessments: Additional intervention(s) to treat staple-line failure
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Chicago
country: United States
facility: Rush
state: Illinois
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Falk Clinic
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas - San Antonio
state: Texas
city: Fredericksburg
country: United States
facility: Mary Washington Hopital
state: Virginia
Study officials:
References: