Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients
| Status: | Withdrawn |
|---|---|
| Conditions: | Orthopedic, Podiatry |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/27/2018 |
| Start Date: | June 13, 2014 |
| End Date: | June 13, 2015 |
To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable
clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.
There are a number of disorders where blood flow is inadequate to provide nutrients and
oxygen to tissues. Under some circumstances, surgery is required to either improve the blood
flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood
supply to an organ is temporarily or permanently performed to minimize blood loss during a
surgical procedure.
Additionally, there are disorders where the location of certain blood containing structures
is important but not immediately obvious to surgeons during an operation. Knowledge of where
those structures are is very important and could greatly improve the safety of various
surgical procedures.
Patients of the investigator who are scheduled for foot surgery will be provided the
opportunity to participate in this research. After giving informed consent, hyperspectral
images will be obtained at various points during the surgical procedure.
As this technology is non-invasive, it is not expected to interfere with or change the
procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved
to a disk for later evaluation.
100 subjects will participate in this study.
clinicians to determine the degree and effectiveness of blood flow to tissues during surgery.
There are a number of disorders where blood flow is inadequate to provide nutrients and
oxygen to tissues. Under some circumstances, surgery is required to either improve the blood
flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood
supply to an organ is temporarily or permanently performed to minimize blood loss during a
surgical procedure.
Additionally, there are disorders where the location of certain blood containing structures
is important but not immediately obvious to surgeons during an operation. Knowledge of where
those structures are is very important and could greatly improve the safety of various
surgical procedures.
Patients of the investigator who are scheduled for foot surgery will be provided the
opportunity to participate in this research. After giving informed consent, hyperspectral
images will be obtained at various points during the surgical procedure.
As this technology is non-invasive, it is not expected to interfere with or change the
procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved
to a disk for later evaluation.
100 subjects will participate in this study.
The hyperspectral imager will be turned on at various time points during surgery, to measure
the spectral wavelengths of tissues. The surgery being performed will in no way be altered by
the imaging device and post surgical follow-up of patients will be standard of care
appropriate to the surgical procedure.
Patients will have HSI performed only during their surgery. They will not receive additional
medications and will have no additional follow up. Participating in this study will not add
extra appointments, procedures, or time requirements for the patient. The patient's medical
record may be referenced for information after the surgery for up to one year. There are no
costs to the patient for participation in this study.
the spectral wavelengths of tissues. The surgery being performed will in no way be altered by
the imaging device and post surgical follow-up of patients will be standard of care
appropriate to the surgical procedure.
Patients will have HSI performed only during their surgery. They will not receive additional
medications and will have no additional follow up. Participating in this study will not add
extra appointments, procedures, or time requirements for the patient. The patient's medical
record may be referenced for information after the surgery for up to one year. There are no
costs to the patient for participation in this study.
Inclusion Criteria:
- Male and female patients
- 18 years or older undergoing foot surgery
- Speak and read English or Spanish.
- Able to provide written informed consent.
Exclusion Criteria:
- Patients unable to give written informed consent
- Patients who cannot speak and read English or Spanish will be excluded.
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