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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03402347
Other study ID # RSP-11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 16, 2019

Study information

Verified date July 2019
Source RSP Systems A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date June 16, 2019
Est. primary completion date June 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Non-ionising radiation
Laser regimes will be applied to ex vivo skin samples.

Locations

Country Name City State
Denmark Department of plastic surgery Z OUH Odense

Sponsors (1)

Lead Sponsor Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thermal damage threshold Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis. Within 3 months
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