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Necrosectomy With Cryotechnology for Accelerated Removal

Study acronym: NECTAR
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion pushed from Apr 2027 to Dec 2028
    • Start date: Apr 2026 to Dec 2026
    • Study completion pushed from Dec 2027 to Jun 2029
    v6
  2. Notable Start date: Jan 2026 to Apr 2026
    • Primary completion date: Dec 2026 to Apr 2027
    • Study completion date: May 2027 to Dec 2027
    v5
  3. Notable Start date: Sep 2025 to Jan 2026
    • Primary completion date: Sep 1, 2026 to Dec 2026
    • Study completion date: Jan 30, 2027 to May 2027
    v4
  4. Notable Primary completion date: Feb 1, 2026 to Sep 1, 2026
    • Start date: Feb 2025 to Sep 2025
    • Site contact updated
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Oct 1, 2024 to Feb 2025
    • Primary completion date: Oct 1, 2025 to Feb 1, 2026
    • Study completion date: Jan 30, 2026 to Jan 30, 2027
    • Site details revised
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas. For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
Trial Details
NCT Number NCT06553651
Lead Sponsor Christopher C. Thompson, MD, MSc
Collaborators: Erbe Elektromedizin GmbH
Conditions
(from sponsor)
Pancreatic Necrosis, Acute Pancreatitis, Acute Pancreatic Necrosis, Necrosis, Necrosis Pancreas, Walled-Off Pancreatic Necrosis
Related terms Necrosis, Pancreatitis, Pancreatitis, Acute Necrotizing
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov