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Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System

NCT03820713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-23

No results posted yet for this study

Summary

Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy. In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.

Conditions

  • Reduction of Postoperative Adhesions

Interventions

PROCEDURE

Concentrate of plasma coagulation factors

The plasma concentrate of coagulation factors is applied to the surgical site.

PROCEDURE

0.9% saline

Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.

Sponsors & Collaborators

  • Eio Biomedical Ltd.

    lead INDUSTRY

Principal Investigators

  • Rafael Miller, MD · EIO Biomedical Ltd., Medical Adviser

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2020-07-15
Completion
2020-07-15

Countries

  • Lithuania

Study Locations

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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 NCT03820713 on ClinicalTrials.gov