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Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915717
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sonavex, Inc.

Brief Summary:
The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.

Condition or disease Intervention/treatment
Free Flap Transfer Malignant Neoplasm Device: EchoMark Device: EchoSure

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Device: EchoMark
    EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring
  • Device: EchoSure
    EchoSure ultrasound scans are performed to monitor the free flap


Primary Outcome Measures :
  1. Surgeon evaluation of improved monitoring ability via questionnaire with likert scale [ Time Frame: Through study completion, an average of 1 year ]
  2. Surgeon evaluation of satisfaction via questionnaire with likert scale [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Flap failure rate [ Time Frame: Through patient stay, up to 5 days post-op ]
  2. Flap takeback rate [ Time Frame: Through patient stay, up to 5 days post-op ]
  3. Flap salvage rate [ Time Frame: Through patient stay, up to 5 days post-op ]
  4. Total cost of hospitalization [ Time Frame: Through patient stay, up to 5 days post-op ]
  5. Time from OR departure to return to OR [ Time Frame: Through patient stay, up to 5 days post-op ]
  6. Nurse evaluation of improved monitoring via questionnaire with likert scale [ Time Frame: Through study completion, an average of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients undergoing free flap surgery
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
  • Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
  • Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

  • Age <18 years old
  • Patient unable to sign informed consent
  • Patient participating in another investigational device or pharmacological study
  • Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915717


Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Beothy    215-614-0036    beothye@uphs.upenn.edu   
Principal Investigator: Steven Cannady, MD         
Sponsors and Collaborators
Sonavex, Inc.
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Responsible Party: Sonavex, Inc.
ClinicalTrials.gov Identifier: NCT03915717    
Other Study ID Numbers: 2019-01
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms