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A Trial of the Arctx Cool Catheter in Acute Pancreatitis

ConditionAcute Pancreatitis (AP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorArctx Medical, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Serum creatinine >1.5 mg/dL or Glomerular filtration rate (GFR) < 30

Current treatment with pancreatic enzyme replacement therapy

Current treatment with hemodialysis or peritoneal dialysis

Treatment for all non-basal cell cancer within the last 1 year

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Control

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ACC SetExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 cells/mm3 or \>10% Immature (band) forms, Respirations \>20 breaths/min or PaCO2 \<32 mmHg.

Time frame
From randomization until oral food tolerance without organ failure or SIRS, assessed up to hospital discharge (Expected average 1 to 10 days).
2

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.

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

Secondary outcomes

1

Time to Oral Food Tolerance

The number of hours from randomization to the time the participant tolerates oral food, defined as eating at least 50% of a low-fat meal of at least 500 calories without an increase in abdominal pain or vomiting. (This endpoint measures food tolerance alone, without the organ failure / SIRS requirement of the primary effectiveness endpoint.)

Time frame
From randomization until oral food tolerance, assessed up to hospital discharge (expected average of 1 to 10 days).
2

Length of Hospital Stay

Length of hospital stay measured from the date of admission to the date of discharge.

Time frame
From hospital admission to discharge (assessed up to approximately 21 days).
3

Conversion to More Severe AP Classification

The percentage of participants who convert to a more severe acute pancreatitis classification, as measured by the Revised Atlanta Classification (mild, moderately severe, or severe), from randomization to discharge.

Time frame
From randomization through the Day 30 (± 14 days) follow-up visit.
4

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

The time from randomization to achievement of Modified Pancreatitis Activity Scoring System (mPASS Score) score of 60 or less. The mPASS score is calculated from the Pancreatitis Activity Scoring System (PASS) score by removing the morphine equivalent dose (MED) component. The theoretical minimum score is 0 and the maximum score does not have a strict cap, but typical scores range into the hundreds, with higher scores indicating greater disease activity. The Modified Pancreatitis Activity Scoring System (mPASS) includes four dynamic variables: * Oral Intake: 0 to 40 points * SIRS Criteria (two or more of the following: 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.): 0 to 100 points (25 points per criterion) * Abdominal Pain: 0 to \~50+ points * Organ Failure: Up to 300+ points (100 points per organ system failing)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arctx Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: