Status:
RECRUITING
Necrosectomy With Cryotechnology for Accelerated Removal
Lead Sponsor:
Christopher C. Thompson, MD, MSc
Collaborating Sponsors:
Erbe Elektromedizin GmbH
Conditions:
Pancreatic Necrosis
Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 infecti...
Detailed Description
Acute pancreatitis is the most common gastrointestinal disease requiring acute hospital admission. Pancreatic necrosis, a serious complication of acute pancreatitis, is the irreversible death of pancr...
Eligibility Criteria
Inclusion
- Subjects aged 18 years and above, inclusive of both males and females.
- Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
- Imaging indicative of ≥30% necrotic material within the pancreas.
- Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
- Subjects able to tolerate repeated endoscopic procedures.
- Capacity for providing informed consent.
- Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
Exclusion
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
- Intervening gastric varices or unavoidable blood vessels within the access tract.
- Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
- Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
- Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06553651
Start Date
January 1 2026
End Date
May 1 2027
Last Update
December 2 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115