A Trial of the Arctx Cool Catheter in Acute Pancreatitis

NCT07698119 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CL909
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Researchers will compare people who get the ACC Set plus standard of care to people who get standard of care alone. This will show whether adding the ACC Set helps. Participants will: Join one of two groups, chosen by chance: the ACC Set plus standard of care, or standard of care alone. Have the cooling tube in place for up to 3 days, if they are in the ACC Set group. Have blood tests and pain checks every few hours during their hospital stay. Return for follow-up visits about 7, 14, and 30 days later.

Conditions

Acute Pancreatitis (AP)

Outcome Measures

Primary Outcomes (2)

• Time to Oral Food Tolerance Without Organ Failure or SIRS

  The number of hours from randomization to the time the participant tolerates oral food without organ failure or systemic inflammatory response syndrome (SIRS). Tolerating oral food is defined as eating at least 50% of a low-fat meal of at least 500 calories without an increase in abdominal pain or vomiting. Organ failure is defined by the Modified Marshall scoring system (a score of 2 or more in any organ system). SIRS is defined as meeting two or more of four criteria: Heart rate \>90 beats/min, Core temperature \<36°C or \>38°C, White blood count \<4000 or \>12000/mm3 or \>10% Immature (band) forms, Respirations \>20/min or PCO2 \<32 mmHg.

  From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (Expected average 1 to 10 days).

• Adverse Events

  All adverse events are evaluated by seriousness, severity, relatedness to the device, and relatedness to the procedure. Events that are both serious and device-related are also assessed for whether they were anticipated. Adverse events in the ACC Set arm are compared to the control arm to identify any increased risk associated with device use.

  From randomization through the Day 30 (± 14 days) follow-up visit following hospital discharge.

Secondary Outcomes (16)

• Time to Oral Food Tolerance

  From randomization until oral food tolerance, assessed up to hospital discharge (expected average of 1 to 10 days).

• Length of Hospital Stay

  From hospital admission to discharge (assessed up to approximately 21 days).

• Conversion to More Severe AP Classification

  From randomization through the Day 30 (± 14 days) follow-up visit.

• Time to Modified Pancreatitis Activity Scoring System (mPASS) Score ≤60

  From randomization until mPASS ≤60, assessed up to hospital discharge (assessed up to approximately 21 days).

• Time to Pancreatitis Activity Scoring System (PASS) Score ≤60

  From randomization to discharge (assessed up to approximately 21 days)

Study Arms (2)

ACC Set

EXPERIMENTAL

Received Arctx Cool Catheter

Device: Treatment

Control

ACTIVE COMPARATOR

Standard of Care - Did not receive Arctx Cool Catheter

Other: Control

Interventions

Treatment DEVICE

Participants in the treatment arm receive standard of care for acute pancreatitis plus the Arctx Cool Catheter (ACC) Set. Standard of care follows American Gastroenterological Association Institute guidance and includes fluid resuscitation, nutrition support, and pain management, with medications given per each institution's standard of care. In addition, the ACC Set is placed and regional pancreatic cooling is started within a total of 48 hours of symptom onset, and the device remains in place for up to 72 hours, with earlier removal at the investigator's discretion. Feeding and the measurement of food tolerance are standardized across both arms, so treatment participants receive the same standardized oral nutrition and the same nutrition, pain, and blood-test assessment schedule as the control arm.

Also known as: Arctx Cool Catheter (ACC) Set

ACC Set

Control OTHER

Participants in the control arm receive standard of care for acute pancreatitis without the ACC Set. Initial management follows American Gastroenterological Association Institute guidance and includes fluid resuscitation, nutrition support, and pain management, with medications given per each institution's standard of care. Feeding and the measurement of food tolerance are standardized across both arms, so control participants receive the same standardized oral nutrition and the same nutrition, pain, and blood-test assessment schedule as the treatment arm.

Control

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for SIRS, defined as meeting two of the following four criteria:
• Temperature \>38°C (100.4°F) or \<36°C (96.8°F)
• Heart rate \>90 beats per minute
• Respiratory rate \>20 breaths per minute or PaCO2 \<32 mmHg
• White blood cell (WBC) count \>12,000/mm³ or \<4,000/mm³, or \>10% immature (band) forms
• Symptom onset within a window of time enabling ACC placement within a total of 48 hours
• Diagnosis of acute pancreatitis by all three of the following criteria at the time of presentation (not referred), significant enough to require hospitalization:
• Abdominal pain consistent with acute pancreatitis (acute onset of persistent, severe, epigastric pain, often radiating to the back)
• Serum amylase and/or lipase greater than 3 times the upper limit of normal
• Characteristic findings on contrast-enhanced CT (CECT). Note: If CT is not standard of care, it will be performed after the patient signs informed consent and all other eligibility criteria are met.
• Signed written informed consent, and willingness and ability to complete follow-up requirements

You may not qualify if:

• Serum creatinine \>1.5 mg/dL
• Current treatment with pancreatic enzyme replacement therapy
• Current treatment with hemodialysis or peritoneal dialysis
• Active malignancy: a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent with no clinical signs or symptoms of the malignancy for at least five years
• Pancreatic calcifications identified by the baseline contrast-enhanced CT (CECT)
• History or evidence of pancreatic surgery
• Uncorrected coagulation abnormalities or currently taking anti-coagulation medication
• Known history of chronic pancreatitis
• Prior history of acute pancreatitis requiring endoscopic drainage procedures and/or necrosectomy
• Recurrent acute pancreatitis within 30 days
• Known esophageal deformity or esophageal trauma, or known ingestion of acidic or caustic poisons
• Recent trans-nasal surgery, severe maxillofacial trauma, or known diseases of the sinus tract
• Nasopharyngeal or esophageal obstruction, diverticula, or stricture
• Septal deviations
• Known esophageal or gastric varices

Sponsors & Collaborators

• Arctx Medical, Inc.: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Cindy Grabowski

CONTACT

6122453733; cgrabowski@arctxmedical.com

Cassie Frye

CONTACT

cfrye@arctxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized 1:1 controlled trial of the ACC Set

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share