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NCT03860493 · ClinicalTrials.gov registry record

Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device

A clinical trial, sponsored by The Cleveland Clinic.

Completed
Registry status
6
Enrollment target

NCT03860493: Completed study, sponsored by The Cleveland Clinic.

NCT03860493 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03860493 has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
6 participants
Enrollment target

Study Summary

1. Primary Objective: Demonstrate that the IC-Flow Imaging device with Indocyanine Green (ICG) is a feasible technique when visualizing and identifying perfusion of organs when compared to The KARL STORZ VITOM II ICG System during open reconstructive surgical procedures 2. Secondary Objective: 1. Evaluate the mean Assessment of handling properties using The IC- Flow versus The VITOM II. 2. Evaluate the mean Surgeon preference Level using The IC- Flow tower, The IC-Flow Hand-held device versus The VITOM II.

Primary Outcome

The vascular perfusion of the tissue studied will be analyzed using the infra red light after injection of indocyanine green (ICG) by using both the Karl Storz Vitom II and the IC-Flow systems.

Interventions

  • PROCEDURE Perfusion evaluation with indocyanine green

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-05-15
Est. Completion 2020-12-31
The Cleveland Clinic

688 total trials

What the finished NCT03860493 record still lists

NCT03860493 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Perfusion evaluation with indocyanine green is the first listed.

NCT03860493 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03860493 about?

NCT03860493 is a clinical study titled "Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device". 1. Primary Objective: Demonstrate that the IC-Flow Imaging device with Indocyanine Green (ICG) is a feasible technique when visualizing and identifying perfusion of organs when compared to The KARL STORZ VITOM II ICG System during open reconstructive surgical procedures 2. Secondary Objective: ...

What is the current status of trial NCT03860493?

This trial is currently completed. The enrollment target is 6 participants. The study started on 2019-05-15. Estimated completion is 2020-12-31.

What interventions are being tested in trial NCT03860493?

The interventions under investigation include: Perfusion evaluation with indocyanine green (PROCEDURE).

Who is sponsoring clinical trial NCT03860493?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03860493, the US trial registry maintained by the National Library of Medicine. NCT03860493 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.