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A First-in-human Trial to Assess the Safety and Performance of the BioCaptis in Healthy Volunteers

NCT05813041 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-07-27

No results posted yet for this study

Summary

Liquid biopsy is a new field in medicine where doctors can look at small molecules in our blood, called DNA, that carry the genetic material that makes us who we are. In some illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified by looking closely at changes in a person's DNA.

The BioCaptis is a new medical device which can capture molecules of DNA, called cell-free DNA, from a person's blood when used in a clinical procedure called apheresis. The purpose of the BioCaptis-1 clinical trial is to confirm that the BioCaptis is suitable for use in healthy volunteers. The main questions the study aims to answer are:

* Is the BioCaptis safe to use in healthy volunteers?
* Can the BioCaptis capture cell-free DNA from human plasma when used in an apheresis procedure?

Following completion of the informed consent process, participants in the study will complete six appointments over the course of the trial. Three of these will be telephone appointments, and three will be in-person visits at the clinical site. The three in-person visits will include:

* Screening Visit where screening tests will be performed to deem the participant suitable for enrollment;
* Procedural Visit during which the participant will undergo the apheresis procedure with the BioCaptis device;
* Post-procedure Follow Up Visit to check the particpant's health following the apheresis procedure.

Conditions

  • Healthy

Interventions

DEVICE

BioCaptis

The BioCaptis is a medical device intended to capture cell-free DNA from peripheral blood for use in liquid biopsy. When used as a cartridge filter during an apheresis procedure in which plasma is passed through the device, the BioCaptis binds cfDNA which can be eluted, concentrated, and used as an input for cancer diagnostic tests.

Sponsors & Collaborators

  • BioCaptiva Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2023-09-30
Completion
2023-09-30

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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 NCT05813041 on ClinicalTrials.gov