Necrosectomy With Cryotechnology for Accelerated Removal

NCT06553651 | Recruiting FDA Device

• 1 other identifier: 2024P002218
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

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

Keywords

Direct Endoscopic Necrosectomy (DEN); Endoscopic Necrosectomy; Pancreatic Necrosectomy; Necrosectomy; Cryotherapy; Cryotechnology

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate

  To evaluate the effectiveness of cryotechnology for the removal of necrotic pancreatic tissue. Achievement of at least 70% removal of necrotic debris from the pancreatic collection being treated, as determined by change in computed tomography (CT) evaluation from baseline to 21 days post-treatment.

  Baseline, Follow-up Visit Day 21

Secondary Outcomes (6)

• Safety and Procedure-Related Adverse Events

  Procedure Day 0, Follow-up Visit Day 21

• Mean Total Procedure Time

  Procedure Day 0, Reintervention (if needed)

• Total Number of Reinterventions

  From Procedure Day 0 through Follow-up Visit Day 21

• Clinical Improvement within 72 Hours

  Baseline, Procedure Day 0, up to 3 days post-procedure

• Duration of Hospital Stay

  From Procedure Day 0 through date of discharge

Study Arms (1)

Cryotechnology Necrosectomy Procedure

EXPERIMENTAL

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.

Device: Cryotechnology Necrosectomy Procedure

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.

Also known as: Cryotherapy

Cryotechnology Necrosectomy Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christopher C. Thompson, MD, MSc: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

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MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis; Necrosis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christopher C. Thompson, MD, MSc

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Ryan, MS

CONTACT

617-525-8266; mryan@bwh.harvard.edu

Samantha Geltz

CONTACT

617-732-5174; sgeltz@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endoscopy

Model Details: Pilot, single-center, open-label, prospective, single-arm clinical study

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 12 months after publication
• Access Criteria: IPD requests should be made directly to the PI who will determine feasibility of the request. Institutional data transfer agreement will need to be executed to share data.

Locations

US (1)