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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • メキシコ
    • Monterrey
      • Nuevo León、Monterrey、メキシコ、64060
        • 募集
        • Especialistas de la Piel y Cirugía, S.C.
        • コンタクト：
          • Hector Leal Leal, Dr.
          • 電話番号：+528119655342
          • メール：hleal@iderma.org

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Circumference of the Target Area at Day 90
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Circumference of the Target Area at Day 30
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants With Treatment-Emergent Adverse Events
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Jeisys Medical Inc

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2026年12月20日

研究の完了 (推定)

2026年12月31日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年9月1日

最初の投稿 (実際)

2026年9月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月3日

QC基準を満たした最後の更新が送信されました

2026年9月1日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • LIN-BD-01-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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