Minimally Invasive Surgical ProceduresNCT05095935
Medtronic Signia SDR Product Surveillance Registry
An observational study of Minimally Invasive Surgical Procedures and Surgical Procedures, Operative, run by Medtronic at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
- What is being tested?
- N/A observational registry
- How many people
- 430 participants
- Where
- 14 sitesUnited States
- Study dates
- 10 Aug 2021to 1 Oct 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Cooper Health System
Camden, New Jersey, 08103
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Rush
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Children's Hospital Colorado
Denver, Colorado, 80045
Duke University Health Systems
Durham, North Carolina, 27705
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Mary Washington Hopital
Fredericksburg, Virginia, 22401
Cedars Sinai Medical Center
Los Angeles, California, 90048
NYU Langone Medical Center
New York, New York, 10016
New York Presbyterian Hospital - Colombia University Medical Center
New York, New York, 10032
UPMC Falk Clinic
Pittsburgh, Pennsylvania, 15213
University of Texas - San Antonio
San Antonio, Texas, 78249
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Medtronic Signia Small Diameter Reload Product Surveillance Registry
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.
- Being tested
- N/A observational registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A observational registryOther
N/A observational registry
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Adult | Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients. Receives: Other: N/A observational registry | |
| Abdominal Adult | Use of Signia SDR for the transection of renal arteries and veins in adult patients. Receives: Other: N/A observational registry | |
| Abdominal Pediatric | Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients. Receives: Other: N/A observational registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During Procedure
Secondary outcomes (6)
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications
Measured: 30 days
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).
Measured: During Procedure
Intraoperative Assessments: Incidence of Staple Line Bleeding
Number of firings that had an incidence of staple line bleeding of >50cc
Measured: During Procedure
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)
Measured: During Procedure
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)
Measured: 30 days
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
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start10 Aug 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Minimally Invasive Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095935
- Sponsor's protocol ID
- Surgical PSR
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2021
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No