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

NCT ID: NCT06317766

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1 Pre-Clinical 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.

Group Type: EXPERIMENTAL

2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy male and female adults between 18-75 years of age.
• Subjects who can read, understand, and sign the Informed Consent Form.
• Subjects willing and able to comply with all study requirements.
• Fitzpatrick skin types I-IV.
• Subjects who have pre-scheduled a body or facial contouring procedure.

Exclusion Criteria

• Subjects with active localized or systemic infections
• Immunocompromised subjects
• Subjects with coagulation disorder
• History of radiation therapy to treatment area
• Subject with a history of lidocaine or ester-based local anesthetics
• Pacemaker or internal defibrillator
• Superficial or metal implants in the area
• Current or history of skin cancer, as well as any other type of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders
• Pregnancy and nursing
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.
• Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
• Any active condition in the treatment area, such as sores, psoriasis eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies or use of anticoagulants.
• Use of medication and herbs known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last 6 months, tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last 3 months or before complete healing.
• Tattoo or permanent makeup in the treatment area.
• Excessively tanned skin from sun, tanning beds or tanning creams within last the two weeks.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

FA Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlomo Assa, President FACorp

Role: STUDY_DIRECTOR

FA Corporation

Jeffrey Kenkel, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Soutwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

UC 20-2023

Identifier Type: -

Identifier Source: org_study_id