Active Clearance Technology (ACT) Registry

NCT ID: NCT02682849

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-10

Study Completion Date

2020-03-31

Brief Summary

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The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

Detailed Description

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Conditions

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Retained Blood Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Retrospective cohort

No interventions assigned to this group

Prospective PleuralFlow cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
2. Patient undergoing cardiac surgery via sternotomy

Exclusion Criteria

1. Robotic surgery
2. Any access via thoracotomy
3. Any condition deemed inappropriate for inclusion by the investigators.
4. Intolerance to implantable silicone materials.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John M. Stulak

OTHER

Sponsor Role lead

Responsible Party

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John M. Stulak

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John Stulak, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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15-006388

Identifier Type: -

Identifier Source: org_study_id