NeuromaPhase 4NCT06164392
Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography
A Phase 4 study testing Indocyanine green in people with Neuroma and Neuroma Amputation, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma, Neuroma Amputation, Neuroma of Upper Limb
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2024to 28 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Clinical diagnosis of neuroma
- Scheduled elective surgery for neuroma excision
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography
Read the 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 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.
- Being tested
- Indocyanine green
- Keywords
- Neuroma, Indocyanine Green, Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, Nerve Repair, Fluorescence Angiography
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called ICG
Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma
| Study group | Role | What they receive |
|---|---|---|
| Neuroma ICG | Experimental | Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroma ICG Fluorescence Angiogram
Nerve Tissue Perfusion as visualized by Fluorescence Angiogram
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start28 Dec 2024 (estimated)
- Primary completion28 Dec 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Why it stopped: The attendings who were to participate did not want to alter their standard neuroma treatment of neurotomy and TMR, as opposed to dissecting the end of all neuromas before neurotomy. No patients were enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Responsible party
- Principal investigator, Gregory A Dumanian, Northwestern University
- Investigators
- Gregory A Dumanian, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164392
- Sponsor's protocol ID
- STU00220008
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography
- ClinicalTrials.gov ID
- NCT06164392
- Acronym / sponsor ID
- STU00220008
- Keywords
- Neuroma, Indocyanine Green, Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, Nerve Repair, Fluorescence Angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The attendings who were to participate did not want to alter their standard neuroma treatment of neurotomy and TMR, as opposed to dissecting the end of all neuromas before neurotomy. No patients were enrolled in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Society for Surgery of the Hand
- Study start
- 28 Dec 2024 (estimated)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroma ICG | Experimental | Drug: Indocyanine greenSubjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Clinical diagnosis of neuroma
- Scheduled elective surgery for neuroma excision
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine greenAlso: ICGIntravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma | Drug | Neuroma ICG |
Primary outcome
Neuroma ICG Fluorescence Angiogram
Time frame: Intraoperative
Nerve Tissue Perfusion as visualized by Fluorescence Angiogram
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Dumanian, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine green in people with Neuroma and Neuroma Amputation, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroma ICG Fluorescence Angiogram (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.