電気刺激ホーム使用（CGM MEPC_2401）による血液循環改善
静電気発生器を用いた家庭用電気刺激装置（CGM MEPC_2401）の血液循環改善における安全性と有効性を評価する単一施設・非盲検・探索的臨床試験
This study is a single-center, open-label, exploratory clinical trial to evaluate the safety and efficacy of a statics electricity generator for improving blood circulation.
調査の概要
詳細な説明
This clinical trial is conducted to evaluate the efficacy and safety of the personal electro-potential generator, CGM MEPC-2401, on the improvement of blood circulation in healthy adult subjects by applying the investigational medical device, the Ceragem Celtron Circulation Chair (CGM MEPC-2401).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Wŏnju、韓国
- Wonju Severance Christian Hospital
-
-
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:
- Adults aged between 19 and 65 years
- Individuals with a BMI of 30.0 kg/m² or less
- Individuals without abnormal findings on hematology tests (CBC)
Exclusion Criteria:
- Patients with uncontrolled hypertension despite medication (defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg measured at rest)
- Patients with medical conditions requiring the use of assistive devices (e.g., pacemaker, artificial joint, stent, prosthesis, etc.)
- Patients with seizure disorders or a history of loss of consciousness (e.g., epilepsy, acute febrile convulsions such as those associated with severe fever, etc.), or those at high risk of electric shock due to such conditions
- Patients with ventricular arrhythmias (e.g., ventricular tachycardia, history of coronary artery bypass surgery, etc.) and patients with neurological disorders (e.g., diabetic neuropathy, etc.)
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 |
|---|---|
|
実験的：CGM MEPC-2401
|
Improving blood circulation device (Ceragem Celltron Circulation Chair) |
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 and percent change in blood flow of the dorsal metacarpal vein
時間枠：from baseline to immediately after a 30-minute application of the investigational device
|
Change and percent change in blood flow of the dorsal metacarpal vein from baseline to immediately after a 30-minute application of the investigational device |
from baseline to immediately after a 30-minute application of the investigational device
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change and percent change in capillary diameter assessed by capillary microscopy
時間枠：from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
Change and percent change in capillary diameter assessed by capillary microscopy from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes) |
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
|
Change and percent change in oxygen saturation (SpO₂)
時間枠：from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
Change and percent change in oxygen saturation (SpO₂) from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes) |
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
|
Change and percent change in blood zeta potential, cellular ATP levels, nitric oxide, membrane potential, and matrix metalloproteinases
時間枠：from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
Change and percent change in blood zeta potential, cellular ATP levels, nitric oxide, membrane potential, and matrix metalloproteinases from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes) |
from baseline to immediately after a 30-minute application of the investigational device (total duration: 30 minutes)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Kwang Yong Shim, MD、Wonju Severance Christian Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
キーワード
その他の研究ID番号
- CG03-KR25BLC101
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。