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NCT07698119

A Trial of the Arctx Cool Catheter in Acute Pancreatitis

Sponsor: Arctx Medical, Inc.

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicenter, Randomized Controlled Trial of the Arctx Cool CatheterTM (ACC) Set in Patients With Acute Pancreatitis "CHILL-AP"

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-08-01

Completion Date

2028-03-31

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Acute Pancreatitis (AP)

Interventions

DEVICE

Treatment

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.

OTHER

Control

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of esophageal, gastric, or duodenal surgery, specifically including gastric bypass * Reduced platelet count below 50,000 * Less than 40 kg of body mass * Known allergy to any device component (polyurethane, barium sulphate, polyvinyl chloride, polycarbonate, nylon, ABS, polyethylene) * Female who is pregnant or nursing * Participated in another investigational drug or therapeutic medical device study within 30 days before randomization * Any history of congestive heart failure * History of peptic ulcer disease and/or H. pylori within the past year * Glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m² (GFR \<30) * Known or suspected diabetic nephropathy * Body mass index ≥40 kg/m², or BMI ≥35 kg/m² with significant comorbidity * Currently using GLP-1 receptor agonists (RAs)