Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
NCT05647096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2024-11-29
Summary
This is a prospective, multinational, multicentre, randomised, parallel-group, open-label 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 sepsis patients.
Conditions
Interventions
- DEVICE
-
NucleoCapture device
100ml NucleoCapture selective DNA adsorber
Sponsors & Collaborators
-
ISS AG
collaborator UNKNOWN -
Santersus AG
lead INDUSTRY
Principal Investigators
-
Andrew Aswani · Santersus AG
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2027-05-05
- Completion
- 2027-05-28
Countries
- Germany
- Switzerland
- United Kingdom
Study Locations
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