An interventional study of Non-ionising radiation in Gastric Bypass Surgery, sponsored by RSP Systems A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by RSP Systems A/S · Not applicable, Interventional, and Basic science
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.
RSP Systems A/S is the lead sponsor of 16 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Non-ionising radiation intervention will be applied to skin explants
Radiation: Non-ionising radiation
Laser regimes will be applied to ex vivo skin samples.
Thermal damage threshold
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.
Time frame: Within 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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RSP Systems A/S