Histological Study of the Effects of a 2910 nm Fiber Laser Technology

Summary

The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.

Part 1 Pre-Clinical Study Procedure:

* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.

Part 2 Clinical Study Procedure:

* 1 healthy adult (male or female)
* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
* The study team will utilize the specific setting based off the results of Part 1.
* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.
* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.
* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.

Conditions

• Skin Laxity

Interventions

DEVICE

2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation

Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.

DEVICE

2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation

Healing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  collaborator OTHER

• FA Corporation

  lead INDUSTRY

Principal Investigators

• Shlomo Assa, President FACorp · FA Corporation

• Jeffrey Kenkel, MD · UT Southwestern Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2024-04-30

Completion

2024-05-31

FDA Device

Yes

Countries

• United States

Study Locations