Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03402347

Enrollment

Registered

2018-01-18

Start date

2019-01-01

Completion date

2019-06-16

Last updated

2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Bypass Surgery

Keywords

Ex vivo, Gastric bypass

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 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.

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 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.

Interventions

RADIATIONNon-ionising radiation

Laser regimes will be applied to ex vivo skin samples.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Excess skin from corrective surgery will be evaluated ex vivo.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026