Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-28

Study Completion Date

2024-12-28

Brief Summary

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

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Detailed Description

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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 Reinnervation is a novel surgical approach to neuroma treatment, resulting in improved residual limb pain in amputees. Nevertheless, a subset of Targeted Muscle Reinnervation patients achieve inadequate relief. Incomplete neuroma excision may be of particular concern in such cases, as failure to completely excise the neuroma risks leaving a scarred proximal nerve stump behind. Despite the critical importance of complete neuroma excision, there is no clear definition of a neuroma's "zone of injury". Indeed, intraoperatively determining where to cut a nerve to ensure accurate and complete excision of a neuroma at the time of reconstruction or repair is an unsolved problem in peripheral nerve surgery. The proposed research aims to characterize the perfusion of neuromas using fluorescence angiography. Specifically, we will test the hypothesis that intravascular indocyanine green (ICG) renders visible the perturbations in nerve perfusion associated with neuromas, and that these altered perfusion patterns correlate with the nerve's "zone of injury" as identified by histopathology. Ultimately, indocyanine green (ICG) fluorescence angiography may facilitate intraoperative decision-making at the time of neuroma excision.

Conditions

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Neuroma Neuroma Amputation Neuroma of Upper Limb Neuroma of Lower Limb

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neuroma ICG

Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma

Interventions

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Indocyanine green

Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma

Intervention Type DRUG

Other Intervention Names

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ICG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No