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Clinical Evaluation of Linear Z for Body Contouring

2026年9月1日 更新者：Jeisys Medical Inc

Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks

This clinical study will evaluate the safety and effectiveness of LinearZ, a non-invasive focused ultrasound device, for body contouring of the lower abdomen and flanks.

Approximately 30 adults with localized fat in the abdomen and flanks will participate in the study. Each participant will receive one treatment with LinearZ to the lower abdomen and flanks and will be followed for approximately 90 days.

The main purpose of the study is to determine whether treatment with LinearZ reduces the circumference of the treated area 90 days after treatment. The study will also evaluate changes in body circumference at Day 30, changes in body contour and appearance, participant satisfaction, body weight, body mass index (BMI), and body composition. Standardized photographs and three-dimensional images will also be used to assess changes in the treated areas.

The safety and tolerability of the treatment will be evaluated throughout the study by monitoring adverse events and treatment-related pain or discomfort.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the safety and effectiveness of LinearZ for non-invasive body contouring of the lower abdomen and flanks.

Approximately 30 eligible adult participants with localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks will be enrolled. All eligible participants will receive a single treatment with LinearZ to the lower abdomen and bilateral flanks. There is no randomization or comparator group in this study.

LinearZ is a focused ultrasound device designed to deliver ultrasound energy at specific depths within subcutaneous tissue for non-invasive body contouring. Treatment will be performed according to predefined study procedures and sponsor-approved treatment instructions. Treatment parameters, including the treatment area, cartridge type, treatment depth, energy level, and number of treatment lines or shots, will be documented.

Participants will undergo screening and baseline assessments before treatment and will return for follow-up assessments approximately 30 and 90 days after treatment.

The primary effectiveness assessment is the change from baseline in the circumference of the treated area at Day 90. Circumference measurements will be performed using standardized procedures at predefined anatomical landmarks.

Additional effectiveness assessments include change in circumference at Day 30, aesthetic improvement, participant satisfaction, changes in body weight and body mass index (BMI), and changes in body composition. Standardized clinical photography and three-dimensional imaging will also be used to document and evaluate changes in body contour. Independent blinded evaluators will review standardized images to help minimize assessment bias.

Safety and tolerability will be evaluated throughout the study by monitoring treatment-emergent adverse events, device-related adverse events, serious adverse events, and treatment-related pain or discomfort. Immediate post-treatment skin reactions and other local responses will also be assessed.

Each participant will participate in the study for approximately 90 days from the day of treatment.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 墨西哥
    • Monterrey
      • Nuevo León、Monterrey、墨西哥、64060
        • 招聘中
        • Especialistas de la Piel y Cirugía, S.C.
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Participants of either sex.
  • Body mass index (BMI) greater than 20 kg/m².
  • Presence of localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks considered adequate for non-invasive body contouring by the investigator.
  • Minimum subcutaneous fat thickness of 30 mm, assessed clinically or by caliper/ultrasound.
  • Stable body weight (±3 kg) for the past 3 months.
  • Willingness to maintain stable diet and exercise habits during study participation.
  • Ability to comply with study requirements.
  • Provision of written informed consent.
  • Compliance with other clinical criteria defined for the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Women planning pregnancy during study participation.
  • Previous body contouring procedures in the treatment area within the past 6 months.
  • Moderate to severe skin laxity in the treatment area that, in the investigator's judgment, is likely to interfere with assessment of body-contouring results.
  • Active dermatologic conditions or infections.
  • Implanted electronic devices, such as a pacemaker or implanted defibrillator.
  • Coagulation disorders.
  • Use of anticoagulant therapy.
  • Severe uncontrolled systemic disease.
  • Participation in another clinical investigation within the previous 30 days.
  • Any contraindication listed in the device manual.
  • Hernia in the treatment area.
  • Metal implants in the treatment area.
  • Significant open scars, tattoos, or wounds in the treatment area.
  • Altered sensation or neuropathy.
  • Active malignancy.
  • History of keloid formation or poor wound healing.
  • Use of weight-loss medications or GLP-1 agonists within the previous 3 months.
  • Previous liposuction or surgery in the treatment area within the previous 12 months.
  • Psychiatric conditions that affect the ability to provide informed consent or that affect body-image perception.
  • Women of childbearing potential who are unwilling to use medically acceptable contraception during study participation.
  • Any participant who, in the investigator's opinion, is not suitable for participation or is unlikely to comply with study procedures or complete the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：A single-arm study where subjects will receive HIFU for non invasive body contouring
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. Treatment will be performed according to the predefined study treatment parameters. Participants will be followed for approximately 90 days after treatment to evaluate the safety and effectiveness of the treatment.
设备：High Intensity Focused Ultrasound
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. The device delivers focused ultrasound energy at specific depths within the subcutaneous tissue. Treatment will be performed according to the sponsor-approved treatment manual, site-specific operating procedures, and study procedures. All participants will receive treatment to both the lower abdomen and flanks during the treatment session and will be followed for approximately 90 days after treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Circumference of the Target Area at Day 90
大体时间：Baseline to day 90
The change in circumference of the treated target area from baseline to Day 90 will be assessed using standardized circumference measurements. The target area includes the lower abdomen and bilateral flanks. Circumference will be measured at a predefined and documented anatomical level using a standardized procedure, and the average of three consecutive measurements will be used for analysis.
Baseline to day 90

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Circumference of the Target Area at Day 30
大体时间：Baseline to Day 30
Change in circumference of the treated target area from baseline to Day 30 will be assessed using standardized circumference measurements at predefined anatomical points encompassing the lower abdomen and bilateral flanks. The average of three consecutive measurements will be used for analysis.
Baseline to Day 30
Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90
大体时间：Baseline to Day 90
Percentage of participants who achieve a reduction of at least 5 cm in circumference of the treated target area compared with baseline.
Baseline to Day 90
Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90
大体时间：Baseline to day 90
Percentage of participants who achieve a reduction of at least 10 cm in circumference of the treated target area compared with baseline.
Baseline to day 90
Global Aesthetic Improvement Scale (GAIS) Score
大体时间：Day 30 and Day 90
Aesthetic improvement of the treated area will be assessed using the Global Aesthetic Improvement Scale (GAIS) at follow-up visits.
Day 30 and Day 90
Blinded Independent Photographic Evaluation of Aesthetic Improvement
大体时间：Baseline, Day 30 and Day 90
Independent blinded evaluators will assess aesthetic improvement using standardized photographs obtained at baseline and follow-up visits.
Baseline, Day 30 and Day 90
Participant Satisfaction With Treatment Outcome
大体时间：Day 30 and Day 90
Participant satisfaction with the treatment outcome will be assessed using the study-specified satisfaction questionnaire.
Day 30 and Day 90
Change From Baseline in Body Weight
大体时间：Baseline to Day 30 and Day 90
Change in participant body weight from baseline will be assessed at follow-up visits.
Baseline to Day 30 and Day 90
Change From Baseline in Body Mass Index (BMI)
大体时间：Baseline to Day 30 and Day 90
Change in BMI from baseline will be assessed at follow-up visits. BMI is expressed in kg/m².
Baseline to Day 30 and Day 90
Change From Baseline in Fat Mass and Fat-Free Mass
大体时间：Baseline to Day 30 and Day 90
Change in fat mass and fat-free mass from baseline will be assessed using the InBody body composition measurement system.
Baseline to Day 30 and Day 90
Procedural Pain and Discomfort Score Using an 11-Point Numeric Rating Scale
大体时间：Immediately after each treatment.
Procedural pain associated with radiofrequency treatment will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater procedural pain.
Immediately after each treatment.

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With Treatment-Emergent Adverse Events
大体时间：From treatment through Day 90
Treatment-emergent adverse events will be monitored from the treatment procedure through the final follow-up visit. Adverse events will be assessed for severity and relationship to the study device/procedure in accordance with the study protocol.
From treatment through Day 90

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jeisys Medical Inc

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月20日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年8月27日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月3日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • LIN-BD-01-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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