NCT06256497暂停不适用
Revita DMR Post Market Pilot Clinical Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical effectiveness
研究概览
简要总结
The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent in accordance with GCP and local legislation
- •Adults (≥18 years) with the diagnosis of T2D
- •BMI of <=45 kg/m2 at the time of presentation/screening
- •T2D mellitus inadequately controlled on therapy (HbA1c ≥7.0 and ≤10.0% [53-86 mmol/mol] at the time of initial presentation for screening and with the need for therapy escalation [dose increase of existing therapy or additional prescription of insulin and/or OADs or change of therapy regimen]) to achieve the therapeutic HbA1c target defined by the physician
- •Treatment with oral and/or injectable glucose lowering medications and/or long-acting insulin therapy
排除标准
- 未提供
结局指标
主要结局
Clinical effectiveness
时间窗: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Changes in antidiabetic medication dosages
次要结局
未报告次要终点
研究者
研究点 (1)
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