NCT03402347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

January 10, 2018

Last Update Submit

July 1, 2019

Conditions

Gastric Bypass Surgery

Keywords

Ex vivoGastric bypass

Outcome Measures

Primary Outcomes (1)

  • Thermal damage threshold

    Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.

    Within 3 months

Study Arms (1)

Laser irradiation regimes

EXPERIMENTAL

Non-ionising radiation intervention will be applied to skin explants

Radiation: Non-ionising radiation

Interventions

Non-ionising radiationRADIATION

Laser regimes will be applied to ex vivo skin samples.

Laser irradiation regimes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of plastic surgery Z OUH

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

Radiation, Nonionizing

Intervention Hierarchy (Ancestors)

RadiationPhysical Phenomena

Study Officials

  • Jens Ahm Sørensen, MD

    Department of plastic surgery Z OUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Excess skin from corrective surgery will be evaluated ex vivo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

January 1, 2019

Primary Completion

June 16, 2019

Study Completion

June 16, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)