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Procedure

Cryotechnology for Pancreatic Necrosis (NECTAR Trial)

N/A
Waitlist Available
Research Sponsored by Christopher C. Thompson, MD, MSc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage
Walled-off pancreatic necrosis (WOPN) size ≥6 cm
Must not have
Inability to provide informed consent
Presence of documented Pseudoaneurysm > 1cm within the WOPN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, follow-up day 21
Awards & highlights

Summary

This trial aims to evaluate the safety and effectiveness of using a cryoprobe, a device that uses extreme cold temperatures, to remove necrotic (dead) pancreatic tissue in patients with pancreatic necrosis

Who is the study for?
This trial is for individuals with severe pancreatitis leading to dead pancreatic tissue, a condition known as necrosis. Participants should be candidates for an endoscopic procedure to remove this tissue. There's no specific mention of exclusion criteria in the provided information, so general health status and other factors will likely be assessed on a case-by-case basis.
What is being tested?
The study tests a new way to perform necrosectomy using cryotechnology—a method that freezes and removes dead pancreatic tissue during an endoscopic procedure. It compares the effectiveness and safety of this approach against traditional methods like forceps or snares.
What are the potential side effects?
While specific side effects are not listed, cryoprobes are generally safe but may include risks typical of endoscopic procedures such as infection, bleeding, or damage to surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a specific procedure for pancreas damage due to severe pancreatitis.
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My pancreatic necrosis is 6 cm or larger.
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I can undergo multiple endoscopies.
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I understand and can agree to the study's procedures and risks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I have a pseudoaneurysm larger than 1cm in my pancreas.
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I am not willing to have multiple endoscopies.
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I have blood vessels in the way of where a doctor would need to go for a procedure.
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I am on blood thinners that cannot be stopped.
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I am not pregnant, breastfeeding, and I use reliable contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, follow-up day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Technical Success Rate
Secondary study objectives
Clinical Improvement within 72 Hours
Duration of Hospital Stay
Mean Total Procedure Time
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cryotechnology Necrosectomy ProcedureExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Erbe Elektromedizin GmbHIndustry Sponsor
12 Previous Clinical Trials
581 Total Patients Enrolled
Christopher C. Thompson, MD, MScLead Sponsor
5 Previous Clinical Trials
5,226 Total Patients Enrolled
~13 spots leftby Oct 2025
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