Abstract:
BACKGROUND AND OBJECTIVES:While cryolipolysis initially received FDA clearance for fat reduction in the abdomen and flanks, there was significant interest in non-surgical fat reduction for other sites, such as the inner and outer thighs. This article reports the results of an inner thigh study which contributed to FDA clearance of cryolipolysis for treatment of thighs. STUDY DESIGN/MATERIAL AND METHODS:A flat cup vacuum applicator (CoolFit applicator, CoolSculpting System) was used to treat 45 subjects bilaterally in the inner thighs. Single cycle treatments were delivered at Cooling Intensity Factor (CIF) 41.6 for 60 minutes followed by 2 minutes of manual massage. Follow-up visits were conducted at 8 and 16 weeks. Efficacy was assessed by ultrasound imaging, circumference measurements, and photographs. Safety was assessed by monitoring adverse events. Patient satisfaction was evaluated by questionnaire. RESULTS:Data is presented for n = 42 patients that completed the 16 week study follow-up and maintained their weight within 5 lbs. of baseline. Independent photo review from three blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicate fat layer reduction of 2.8 mm. Circumferential measurements indicate mean reduction of 0.9 cm. Patient questionnaires reveal 93% were satisfied with the CoolSculpting procedure; 84% noticed visible fat reduction; 89% would recommend to a friend; and 91% were likely to have a second treatment. There were no device- or procedure-related serious adverse events. CONCLUSION:The CoolFit flat cup vacuum applicator was found to deliver safe and effective cryolipolysis treatment to reduce inner thigh fat. Completed 16-week data from 42 subjects show 2.8 mm reduction in fat thickness and 0.9 cm reduction in circumference. Assessment of clinical photographs found 91% correct identification of baseline images. The results of this prospective, multi-center, interventional clinical study contributed to FDA clearance of cryolipolysis for treatment of thighs in April 2014.
journal_name
Lasers Surg Medjournal_title
Lasers in surgery and medicineauthors
Zelickson BD,Burns AJ,Kilmer SLdoi
10.1002/lsm.22320subject
Has Abstractpub_date
2015-02-01 00:00:00pages
120-7issue
2eissn
0196-8092issn
1096-9101journal_volume
47pub_type
临床试验,杂志文章,多中心研究abstract::New instruments to facilitate laser operations are presented. These devices are based on the Kocher bronchocoele sound and are useful as dissecting tools and optical backstops to prevent iatrogenic injury. ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900100613
更新日期:1990-01-01 00:00:00
abstract::To date, there are two fairly well-established alternatives for laser-induced shock-wave lithotripsy in clinical practice. The Q-switched Nd:YAG laser is distinguished by the high-stone selectivity of its coupler systems. The necessity of a coupler system and its fairly small conversion rate of light energy into mecha...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900080405
更新日期:1988-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:We evaluated the potential of combining laser excision with laser interstitial hyperthermia in order to improve the quality of life of patients with 3rd or 4th stage malignant head and neck tumours. STUDY DESIGN/MATERIALS AND METHODS:To evaluate the quality of life, we used the 4th version of...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.10253
更新日期:2004-01-01 00:00:00
abstract::Histological investigation of the dog's myocardium performed 7 and 25 days after irradiation with different doses of Nd-YAG laser show that the damage zone has the shape of a hollow sphere with minor changes in cardiomyocytes in the central part of the sphere. The small blood vessels in the irradiated zone remained un...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900050506
更新日期:1985-01-01 00:00:00
abstract:BACKGROUND/OBJECTIVES:Current laser therapy of port wine stain (PWS) birthmarks with a single laser pulse (SLP) does not produce complete lesion removal in the majority of patients. To improve PWS therapeutic efficacy, we evaluated the performance of an approach based on multiple laser pulses (MLP) to enhance blood ves...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.22000
更新日期:2012-02-01 00:00:00
abstract::A technique for partial nephrectomy using a combination of an Ultrasonic Surgical Aspirator and a neodymium:YAG laser provided better hemostasis and decreased total operative time compared to standard methods. Delayed hemorrhage was not seen, and thermal damage to the remaining renal parenchyma was minimal. ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900060210
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:In recent years, clinical low-intensity laser therapy practice has used pulsed radiation, mainly from semiconductor lasers. Experimental works devoted to the study of relationships between biological and clinical effects and parameters of pulsed radiation are practically absent. STUDY DESIGN/M...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/(sici)1096-9101(1997)21:5<485::aid-lsm11>3
更新日期:1997-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Linear birefringence is an anisotropic property of rat tail tendon, which is largely composed of collagen. Our goal is to show that the dynamic range and sensitivity of the linear birefringence loss of collagen during heating are sufficient for kinetic modeling of the reaction. STUDY DESIGN, M...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/(sici)1096-9101(1997)20:3<310::aid-lsm10>3
更新日期:1997-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Short pulsed and scanned CO(2) lasers that target water molecules are currently used for cutaneous resurfacing. These CO(2) resurfacing lasers produce acute cutaneous contraction, which can be quantitated as a measure of the laser's effect. We postulated that targeting the vibrational and rotat...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/(sici)1096-9101(1999)25:1<1::aid-lsm1>3.0.
更新日期:1999-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Helicobacter pylori (HP) is an endemic pathogenic bacterium causing gastritis and gastroduodenal ulceration in humans and is linked to the development of gastric malignancies. These first human in vivo studies investigated the photoeradication of HP using laser and white light. STUDY DESIGN/M...
journal_title:Lasers in surgery and medicine
pub_type: 临床试验,杂志文章
doi:10.1002/lsm.10066
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:This study was conducted to clarify the morphologic characteristics and subsequent repair process of coagulation necrosis produced by pulsed CO(2) laser irradiation with relatively low fluence, and thereby to evaluate the clinical efficacy of this irradiation mode. STUDY DESIGN/MATERIALS AND ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.20712
更新日期:2008-12-01 00:00:00
abstract::A laser endoscope was devised using optic fibers in order to provide a means of visualization and removal of atheromatous plaques from arteries in cadavers and experimental animals. Atheromatous plaques were satisfactorily lased off in a few seconds, although contraction of lased vessels was observed. A self-focusing ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900040408
更新日期:1984-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Interstitial laser therapy (ILT) is a minimally invasive treatment method for congenital vascular malformations (CVM). This study was intended to show whether or not open magnetic resonance imaging (MRI) offers a means of on-line thermometry and procedure control. STUDY DESIGN/PATIENTS AND MET...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/(sici)1096-9101(1998)23:5<250::aid-lsm4>3.
更新日期:1998-01-01 00:00:00
abstract::Laser recanalization using metal capped fibers occurs by thermal vaporization of occluding plaque. However, little is known about the effects of blood and flow on the temperature of the laser probe or the arterial wall during lasing. To study this, probe and arterial wall temperatures were measured while a metal cappe...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900080603
更新日期:1988-01-01 00:00:00
abstract:INTRODUCTION:Leg telangiectasias have been reported to have been treated with a variety of lasers. This study was designed to measure response to treatment of leg telangiectasias with a unique coupled 585 nm and 1064 nm pulse. METHODS:Sixty female patients (24-62 y.o., skin types II-IV) with leg vein varicosities were...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.20972
更新日期:2010-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The Holmium: YAG (Ho: YAG) laser has been used for the ablation of prolapsed discs but alternative techniques are available, and this application remains controversial. It also has potential for the decompression of nerve roots within narrowed foraminae with the technique of endoscopic laser fo...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1083
更新日期:2001-01-01 00:00:00
abstract::The distribution of light in laser-irradiated biological medium is computed using four different procedures. Values computed with Beer's law of attenuation, Kubelka-Munk theory, the diffusion approximation, and a seven-flux model are compared. The proper conditions for using each model are discussed. ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900060603
更新日期:1987-01-01 00:00:00
abstract::Percutaneous endoscopic approaches to cholelithiasis would be facilitated by methods for welding gallbladder tissues. We evaluated the bursting pressure and histologic appearance of canine gallbladder tissue welded with a thulium-holmium-chromium:YAG (THC:YAG) laser producing a 2.15 microns pulsed output. The tissue a...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900090211
更新日期:1989-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Nanotechnology may increase the speed of penetration into the skin. This study evaluated the efficacy, safety, and pharmacokinetics of a novel topical anesthetic nanocapsule formulation (2 g) containing 2.5% lidocaine and 2.5% prilocaine (nanorap-test formulation) compared to placebo (control ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章,随机对照试验
doi:10.1002/lsm.23071
更新日期:2019-09-01 00:00:00
abstract::There are a host of fiber-optic delivery devices available for use with the Er:YAG, HF, CO, and CO2 lasers at 2.9, 2.8, 5.3, and 10.6 microns wavelengths, respectively. While many of these fibers are not as convenient to use as conventional silica fibers, they offer the ability to deliver infrared laser energy for a w...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章,评审
doi:10.1002/lsm.1900130513
更新日期:1993-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:It is established that both pulsed Nd:YAG (1,064 nm) and continuous diode (810 nm) dental lasers kill pathogenic bacteria (laser antisepsis), but a quantitative method for determining clinical dosimetry does not exist. The purpose of this study was to develop a method to quantify the efficacy ...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.20086
更新日期:2004-01-01 00:00:00
abstract::A 63 year old male underwent 6,900 rads of external radiation for a squamous cell carcinoma of the left main bronchus. Recurrence of the tumor 8 months later was treated with 6,618 joules and patency of the left main bronchus was restored. Four months later, he developed complete atelectasis of the left lung requiring...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900120316
更新日期:1992-01-01 00:00:00
abstract::Patients with malignant obstructive airway lesions often present with total or segmental atelectasis of lung. In spite of prompt initiation of palliative external radiation alone, some patients were unable to complete the planned course of radiation therapy. Since May 1983, 17 patients with malignant obstructive endob...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900050107
更新日期:1985-01-01 00:00:00
abstract::We describe our experience and the problems we encountered organizing an autonomous surgical unit in which the equipment and organization enable three lasers to be used in may different applications in medicine and surgery. The three lasers--CO2, Nd:YAG, and argon--may now be used by all the departments concerned with...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900030102
更新日期:1983-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The purpose of this investigation was to evaluate: 1. thermal events during laser irradiation @2.1 microns of the pulp; 2. whether these effects are adequately modeled using an empty pulp chamber/root canal. STUDY DESIGN/MATERIALS AND METHODS:In extracted human teeth, pulpal access was prepare...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/(sici)1096-9101(1998)22:1<46::aid-lsm11>3.
更新日期:1998-01-01 00:00:00
abstract::The healing of standardized fracture of rabbit radius was expedited as a result of treatment with low-power CO2 laser irradiation. Observation with transmission electron microscope revealed the following favorable effects of CO2 laser irradiation: The red blood cells were induced to disintegrate, thus promoting the ab...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.1900060309
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:To investigate the morphology of cementum and root dentin after Er:YAG laser irradiation with and without water coolant, compared to that after CO(2) laser irradiation and an untreated surface. STUDY DESIGN/MATERIALS AND METHODS:Ten extracted healthy human teeth were used. Er:YAG and CO(2) la...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.10074
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Recently developed laser lipolysis systems have been disappointing because they require more time to remove the same amount of fat than other liposuction methods. A new Nd:YAG laser has been introduced that uses the 1,444 nm wavelength, better absorbed by fat. STUDY DESIGN/MATERIALS AND METHO...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.20786
更新日期:2009-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:In this study, methylene blue-mediated photodynamic therapy (MB-PDT) was used as a possible alternative method for the treatment of oral lichen planus (OLP). STUDY DESIGN/MATERIALS AND METHODS:Thirteen patients with 26 OLP lesions were enrolled in this study. Patients were instructed to gargl...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/lsm.20278
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Understanding albumin solder denaturation is important for laser tissue soldering. Human (HSA), bovine (BSA), porcine (PSA), and canine (CSA) albumin both fatty acid containing (FAC) and fatty acid free (FAF) were evaluated by using differential scanning calorimetry (DSC). STUDY DESIGN/MATERIA...
journal_title:Lasers in surgery and medicine
pub_type: 杂志文章
doi:10.1002/1096-9101(2000)27:5<465::AID-LSM1007>3.0.C
更新日期:2000-01-01 00:00:00