A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients
A Prospective Clinical Trial of the TANTALUS System In Treatment of Obese to Morbidly Obese Patients
調査の概要
詳細な説明
This is a prospective multi center, non-randomized, treatment only clinical trial with up to thirty (30) obese with type 2 diabetes subjects. The study is designed to demonstrate that use of the rechargeable TANTALUS II IPG is safe and that it functions as designed.
Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
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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California
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Los Angeles、California、アメリカ、90048
- Cedars Sinai
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Texas
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San Antonio、Texas、アメリカ、78229
- Diabetes and Glandular Disease Clinic (DGD)
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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:
- Age 21-70 years
- Diabetic subjects having HbA1c greater than or equal to 7.5% and less than or equal to 9.5 % at Visit 1
- Sex: male or female. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
- Type 2 diabetes duration less than 10 years but at least 6 months
- Type 2 diabetic Subjects taking no more than two (2) oral anti-diabetic agents [Sulfonylurea, Metformin or thiazolinedione (TZD)].
- Stable anti-diabetic drugs for at least three (3) months prior to enrollment and six (6) months for thiazolinedione (TZD).
- Fasting blood glucose values > 120 and < 240 mg/dl at baseline
- Stable HbA1c, described as no significant change (≤ 0.5% variation) between a historical value in the subjects' medical record within 3 months prior to enrollment and the A1c value gathered at baseline.
- If subject is under anti-depressant medication, the treatment needs to be stable for at least six (6) months prior to enrollment.
- BMI between 28 and 45 (kg/m2)
- Stable weight, defined as no significant weight change over the three months prior to enrollment as reported by the subject (±5 kg).
- Stable medications (including anti-hypertensive and lipid-lowering) for at least one month prior to enrollment.
- Compliant, willing and able to participate in the follow-up visits for the study duration.
- Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial.
- Able to provide voluntary informed consent.
Exclusion Criteria:
- Gastroparesis or intestinal pseudo-obstruction.
- Receiving medications known to affect gastric motility.
- Taking appetite suppressant or weight loss medications within 1 month of enrollment.
- Diabetic subjects on insulin.
- Past or current psychiatric condition that may impair his or her ability to comply with the study procedures.
- Severe eating disorders such as bulimia or binge eating.
- Obese due to a clinically diagnosed endocrine problem.
- Pregnant (proven by positive βhCG), or lactating.
- History of anemia (<10 g/dl) over past 3-months.
- Prior bariatric surgery.
- History of peptic ulcer disease.
- Use of another investigational device or agent in the 30 days prior to enrollment.
- Participation in another clinical study.
- Life threatening co-morbidity or life expectancy of less than one year.
- Myocardial Infarction or one or more episodes of unstable angina within six months prior to enrollment.
- Implanted with a permanent pacemaker, an automatic implantable defibrillator, or other electro-stimulation device.
- History of life threatening disease within 5 years of enrollment.
- Use of routine ulcerogenic drugs.
- Use of prescription, over the counter or herbal weight loss products.
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:Implanted Device
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Subjects will undergo an approximately two week baseline screening process.
Eligible subjects will undergo device implantation.
This will be followed by therapy initiation approximately one week after implantation.
The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy.
Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
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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 |
時間枠 |
---|---|
Safety Evaluation
時間枠:June 2004-September2009
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June 2004-September2009
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Device Functionality Evaluation
時間枠:June 2004-September2009
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June 2004-September2009
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Change in HbA1c
時間枠:June 2004-September2009
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June 2004-September2009
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Percentage of body weight loss
時間枠:June 2004-September2009
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June 2004-September2009
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Harold Lebowitz, MD、Proffesor of Medicine, Endocrinology and Metabolism/Diabetes, State University on NY Health Science
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
rechargeable TANTALUS IIの臨床試験
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MetaCure (USA), Inc.終了しました
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Sun Pharmaceutical Industries LimitedMoebius Medical Ltd.; Nordic Bioscience Clinical Development (NBCD)完了
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St. Olavs HospitalSmith & Nephew, Inc.まだ募集していません
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Psychiatric Centre RigshospitaletUniversity of Copenhagen; IT University of Copenhagen完了
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Smith & Nephew, Inc.引きこもった関節形成術 | 膝 | 置換シンガポール, 中国, インド