Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs
Effect of BTL-899 Device for Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs
調査の概要
詳細な説明
This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of inner thighs. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit, MRI imaging will be performed; the subject's weight and thigh circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicator of BTL-899 will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive a Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), including the subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo a MRI imaging. Also, the subject's satisfaction will be noted, and weight with thigh circumference will be recorded. Photographs of the treated area will be taken. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Colorado
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Fort Collins、Colorado、アメリカ、80525
- Plastic Surgical Associates
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Pinchable fat layer at the thigh region
- Age > 21 years
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
Exclusion Criteria:
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- Intrauterine device (IUD)
- Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
- Basedow's disease
研究計画
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 |
|---|---|
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実験的：Experimental
Subjects will be required to complete four (4) treatment visits and two follow-up visits.
All of the study subjects will receive the treatment with the subject device
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患者の許容閾値をわずかに下回る強度の磁場と高周波エネルギーによる治療。
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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 |
|---|---|---|
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The evaluation of structural changes of subcutaneous tissues of the inner thighs
時間枠：4 months
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The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues.
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4 months
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The evaluation of structural changes of subcutaneous tissues of the inner thighs
時間枠：4 months
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The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through evaluation of tissue composition and morphology.
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4 months
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The evaluation of change in adipose layer thickness
時間枠：4 months
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The evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on thigh circumference measurements.
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4 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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治療快適性アンケートによって測定される治療の安全性の評価
時間枠：4ヶ月
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転帰はさらに、有害事象の発生またはその欠如によって測定されます。
数値アナログスケール (0 ～ 10) で、0 は「痛みなし」を表し、10 は「考えられる最悪の痛み」を表し、治療中に経験する痛みのレベルを選択します。
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4ヶ月
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Patient's satisfaction with study treatment measured via questionnaires
時間枠：4 months
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To determine the patient's satisfaction with study treatment for non-invasive lipolysis and improvement of muscle tone in inner thighs.
The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome.
Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.
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4 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脂肪障害の臨床試験
BTL-899の臨床試験
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BTL Industries Ltd.完了