Necrosectomy With Cryotechnology for Accelerated Removal

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Christopher C. Thompson, MD, MSc
Study ID
NCT06553651
Status
Recruiting
Apply to this trial

Conditions

  • Acute Pancreatic Necrosis
  • Acute Pancreatitis
  • Necrosis
  • Necrosis Pancreas
  • Pancreatic Necrosis
  • Walled-Off Pancreatic Necrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryotechnology Necrosectomy Procedure — DEVICE
    Subjects undergo necrosectomy with 1.7 mm flexible cryoprobes, either concurrently with stent placement or post-placement, at the Investigator's discretion. The cryoprobe will freeze the necrotic tissue and extracted en-bloc. A maximum of 4 cryotechnology procedures will be performed, with each procedure aiming for significant debris removal and clinical improvement of walled-off pancreatic necrosis (WOPN) symptoms.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cryotechnology Necrosectomy Procedure
    Enrolled subjects will undergo direct endoscopic necrosectomy using 1.7 mm single use, flexible cryoprobes, aimed at effectively removing necrotic tissue within the pancreatic cavity.

Primary Outcome Measure

Technical Success Rate [ Time Frame: Baseline, Follow-up Visit Day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele B. Ryan, MS
[email protected]
6175258266
Christopher C. Thompson, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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