Skip to main content
OpenTrials
Completed

NCT Number: NCT05095935

Medtronic Signia SDR 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Minimally Invasive Surgical Procedures Surgical Procedures, Operative

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N/A observational registry

Other

N/A observational registry

Primary outcomes

  1. Incidence of Intraoperative Hemostatic Intervention

    Time frame: During Procedure

    • 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).

Secondary outcomes

  1. Incidence of Repeat Hospital Admission for Primary Procedure-related Complications

    Time frame: 30 days

  2. Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale

    Time frame: During Procedure

    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).

  3. Intraoperative Assessments: Incidence of Staple Line Bleeding

    Time frame: During Procedure

    Number of firings that had an incidence of staple line bleeding of >50cc

  4. Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure

    Time frame: During Procedure

    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)

  5. Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure

    Time frame: 30 days

    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)

  6. Device Deficiencies

    Time frame: 30-days

    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

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Medtronic Signia Small Diameter Reload Product Surveillance Registry

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2021
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.