CTRI/2022/05/042448尚未招募未知
Prospective, single-center, non-randomized, open label, single arm study to evaluate the safety and efficacy of NobiX system. - NA
Allevetix Medical Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female patients
- •2. Patient is at least 18 years old
- •3. Anticipated life expectancy of at least 1 year from enrolment
- •4. Patient providing written Informed Consent prior to any study related procedures
- •5. Patient is willing to comply with the Clinical Investigational Plan (CIP) requirements including return to the study center for all required clinical evaluations
- •6. Patients with baseline BMI of greater than equal to 30 kg per m2 and less than equal to 45 kg per m2
- •7. Type II Diabetes mellitus with HbA1c greater than equal to 7 in the 6 months before enrolment
- •8. Sexually active women, unless surgically sterile or post-menopausal, must use one of the
- •following methods to avoid pregnancy during the study:
- •1. Abstinence from penile/vaginal intercourse during the study;
- •2. Double barrier contraceptive methods one of which must be a condom
排除标准
- •1. Use of weight loss medications, or appetite suppressants during one month prior to enrollment.
- •2. Use of non-steroidal anti-inflammatory drugs, corticosteroids, and drugs known to affect gastrointestinal motility during 3 months prior to enrollment.
- •3. Patients who have taken Antiplatelet medications, Coumadin or Direct Oral Anti-coagulants 10 days prior to the device placement.
- •4. Recent Pancreatitis in the last 1 month, any history of coronary artery disease, Chronic Obstructive Pulmonary Disease (COPD), biliary disease (gallstone, choledocholithiasis), severe coagulopathy.
- •5. History of congenital or acquired gastrointestinal tract disorders, including gastrointestinal bleeding conditions
- •6. Patients having anemia/ iron deficiency
- •7. Patients with known peptic ulcer, gastritis, duodenitis, esophagitis, varices
- •8. History or symptoms of scleroderma
- •9. Previous surgery in the gastrointestinal tract that could affect the ability to place the study device
- •10. Current active infection (excluding H. pylori infection for which antibiotic treatment is initiated10 days before device implantation)
- •11. Any malignancy
- •12. HIV, HCV, HBV positive
- •13. Alcohol abuse
- •14. Pregnant female or intention to become pregnant during the study period
- •15. Patients with confirmed novel coronavirus infection (COVID-19)
- •16. Any other medical condition or serious intercurrent illness that, in the opinion of the Principal Investigator, may make it undesirable for the patient to participate in the study.
研究者
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