Status:
COMPLETED
Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
Lead Sponsor:
RSP Systems A/S
Conditions:
Gastric Bypass Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 histolo...
Detailed Description
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 temperat...
Eligibility Criteria
Inclusion
- Male and female subject 18 years of age or older
- Gastric bypass operated or similar
- Excess abdominal skin to be removed surgically
- Abdominal skin tone 4 or below
Exclusion
- Extensive skin changes, tattoos or diseases on skin explant to be donated
- Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03402347
Start Date
January 1 2019
End Date
June 16 2019
Last Update
July 2 2019
Active Locations (1)
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1
Department of plastic surgery Z OUH
Odense, Denmark, 5000