SmartPAN PMCF study results are published

02/04/2025

We are excited to share the results of the recent SmartPAN post-market trial for elective pancreatic resections. The study assessed SmartPAN’s usability, safety, and its ability to detect intraoperative pancreatic leakage.

Visualization of Intraoperative Pancreatic Leakage (ViP): The IDEAL Stage I First-in-human, Single-arm Clinical Pilot Trial of SmartPAN

Key Insights

  • This post-market trial aimed to evaluate SmartPAN in its intended clinical environment of elective pancreatic resections when used per label directions. The primary aims were to confirm the usability and safety of applying SmartPAN, including an assessment of previously unknown side effects or contraindications. A secondary aim was to measure the rate of intraoperative pancreatic leakage, as the lack of tractable indicators means there are few reliable estimates.
  • The study was a first in a human single-arm trial
  • The study demonstrated SmartPAN clinical use according to its intended purpose with no associated adverse events.
  • The data provide some of the first reliable measurements of the rate of intraoperative pancreatic leakage. Following completed pancreatic surgery, SmartPAN indicated pancreatic fluid leakage in 10 of 29 patients, indicating that at the time of completed surgery, up to 1/3 of the patients had a non-tight closure
  • All surgeons agreed SmartPAN was easy to learn and use (i.e., removal from package, application to site, and removal from body), and most agreed SmartPAN was useful to their work. Most surgeons agreed they would use SmartPAN frequently.

For further details and to access the full publication, please click here