A Trial of the Arctx Cool Catheter in Acute Pancreatitis
Starting soon · Not applicable
Conditions studied: Acute Pancreatitis (AP)
In brief
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.
Key facts
- Study ID
- NCT07698119
- Run by
- Arctx Medical, Inc.
- People needed
- 200
- Starts
- 2026-08-01
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-07-13
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- 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
Full record on ClinicalTrials.gov
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