Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis

Sponsor
Liverpool University Hospitals NHS Foundation Trust
Study ID
NCT06566638
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NucleoCapture device — DEVICE
    100ml NucleoCapture selective DNA adsorber.

Study Details

This is a single-centre, randomised-controlled, open-label, feasibility study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in patients with severe acute pancreatitis.

Key Dates

Start date
Dec 1, 2025
Status verified
Jul 2024
Primary completion
Dec 5, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SOC plus NucleoCapture
    Participants in the treatment arm will receive SOC plus three apheresis treatment sessions with the NucleoCapture device. The device consists of 100ml NucleoCapture selective adsorber.
  • No Intervention: SOC
    Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines.

Primary Outcome Measure

The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment. [ Time Frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated. ]

Central Contacts

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