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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, follow-up day 21

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met