Status:

WITHDRAWN

Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

American Society for Surgery of the Hand

Conditions:

Neuroma

Neuroma Amputation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography

Detailed Description

Neuromas represent the frustrated regeneration of injured nerve axons encased in a bulbous scar. Symptomatic neuromas are particularly problematic in patients with amputations. Targeted Muscle Reinner...

Eligibility Criteria

Inclusion

  • Age \> 18 years
  • Clinical diagnosis of neuroma
  • Scheduled elective surgery for neuroma excision

Exclusion

  • Minors, or age \< 18 years old at the time of surgery
  • Unable to provide written, informed consent
  • Prisoners and decision-impaired individuals
  • Pregnant or lactating women
  • History of allergy to indocyanine green
  • History of allergy to iodides
  • History of allergic asthma
  • History of hepatic failure
  • History of renal failure
  • Patients in whom the planned surgical incision/approach does not include excision of the neuroma
  • Patients in whom adequate surgical exposure of the neuroma is unable to be obtained, as determined intraoperatively at the time of surgery by the Investigator or Co-Investigators
  • Any subject who, at the discretion of the Investigator or Co-Investigators, is not suitable for inclusion in the study

Key Trial Info

Start Date :

December 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 28 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06164392

Start Date

December 28 2024

End Date

December 28 2024

Last Update

January 1 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Northwestern University

Chicago, Illinois, United States, 60657

Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography | DecenTrialz