NCT06317766Unknown不适用
Histological Study of the Effects of a 2910 nm Fiber Laser Technology
FA Corporation2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2024年2月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Mason's Trichrome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Part 1 Pre-Clinical Procedure
Experimental
- 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.
干预措施: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation (Device)
Part 2 Clinical Study Procedure
Experimental
- 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.
干预措施: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation (Device)
结局指标
主要结局
Mason's Trichrome
时间窗: Up to 30 days
The structural analysis using Trichrome will be observational to demonstrate any deviation from the normal skin structure (descriptive tool).
TUNEL Staining
时间窗: Up to 30 days
Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) is a robust technique for detecting apoptosis or cell death. Fluorescence intensity of the TUNEL positive cells in the treatment groups compare to control (untreated) will be measured. The data is given as fold change or percentage.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Study of 18F-FAPI-RGD in Breast TumorsBreast TumorsNCT05976620Sichuan Provincial People's Hospital30
进行中（未招募）
不适用
fMRI Study of the Neural Mechanism of rTMS in the Treatment of Nicotine DependenceTobacco Use DisorderRepetitive Transcranial Magnetic StimulationNCT06762535Tang-Du Hospital50
已完成
不适用
Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral AbdomenFat BurnNCT05540080BTL Industries Ltd.46
已完成
1 期
Safety Tolerability and Pharmacokinetic of BI 409306HealthyNCT01343706Boehringer Ingelheim80
已完成
不适用
Clinical Study of 18F-FAPI-RGD in Ovarian CancerObservationalNCT06614062Sichuan Provincial People's Hospital30