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Principal Investigator left the institution
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The purpose of this study is to demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. In addition, we seek to measure the effectiveness and utility of this class 4 laser therapy in the treatment of post-thoracotomy pain syndrome.
This study was terminated prior to enrollment and closed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | To demonstrate the safety of the AvicennaTM class IV laser for application over the skin of human subjects. This study was terminated prior to subject enrollment and closed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AvicennaTM class IV laser application | Device | AvicennaTM class IV laser for application over the skin of human subjects in the treatment of post-thoracotomy pain syndrome. Six sessions, twenty minutes applications over a period of six weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The McGill pain questionnaire | 6 Treatments/6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The visual analog scale | 6 Weeks | |
| An infrared thermometer will measure skin temperature before and after the treatment | 6 Treatments/6 Weeks | |
| A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin redness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Rubin, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10065 | United States |
Not Applicable, study terminated prior to enrollment and closed
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Not applicable, study terminated prior to enrollment and closed.
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| 6 Treatments/6 Weeks |
| A 4-point Likert scale (none, mild, moderate, and severe) will be used to document skin tenderness | 6 Treatments/6 Weeks |
| At the end of the study patients will rate their satisfaction with the treatment using an 11 point Likert scale where 0 means completely dissatisfied and 10 means completely satisfied. | 6 Treatments/6 Weeks |