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A Trial of the Arctx Cool Catheter in Acute Pancreatitis

NCT07698119 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-13

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Arctx Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-12-31
Completion
2028-03-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698119 on ClinicalTrials.gov