Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06553651

Necrosectomy With Cryotechnology for Accelerated Removal

Led by Christopher C. Thompson, MD, MSc · Updated on 2026-03-02

20

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

C

Christopher C. Thompson, MD, MSc

Lead Sponsor

E

Erbe Elektromedizin GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Necrosectomy With Cryotechnology for Accelerated Removal

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 18 years and above, including males and females
  • Patients with symptomatic pancreatic necrosis from acute pancreatitis, indicated for endoscopic necrosectomy after endoscopic ultrasound-guided drainage
  • Imaging showing at least 30% necrotic tissue in the pancreas
  • Walled-off pancreatic necrosis size of 6 cm or greater
  • Ability to tolerate repeated endoscopic procedures
  • Capacity to provide informed consent
  • Willingness and ability to attend follow-up assessments through 21 (+/- 7) days
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Unwilling to undergo repeated endoscopies
  • Presence of documented pseudoaneurysm larger than 1 cm within the walled-off pancreatic necrosis
  • Presence of gastric varices or unavoidable blood vessels within the access tract
  • Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily stopped
  • Any condition that compromises safety for endoscopic procedures as judged by the investigator
  • Pregnancy, breastfeeding, or lack of reliable contraception in women who can become pregnant
  • Currently enrolled in another investigational trial that may affect this study's results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Michele Ryan, MS

CONTACT

S

Samantha Geltz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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