Leistung Und Sicherheit Des Trans-Duodenal Barrier (LuST)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- Main Outcome Measure HbA1c reduction
研究概览
简要总结
Approval study Trans-Duodenal Barrier The goal of this clinical trial is to determin the safety and performance of the newly developed Trans-Duodenal Barrier in adult Tryp 2 diabetic and obese patients.
The Trans-Duodenal Barrier is an endoscopic implant which can be placed to the gastric outlet and the upper small bowel by interventional endoscopy. It consists of a 60 cm long foil tube , a transpyloric shaft and and two ringlike balloons to fix it at the pylorus. It will be removed after 6 months via gastroscopy.
The main questions it aims to answer are:
- Does the Trans-Duodenal Barrier lower the HbA1c of the participants ?
- How frequent are adverse side effects related to the device?
- How much ist the excessive wight loss of treated patients ?
- Show patients with Metabolic assiociated Hepatosteatitis (MASH) improvements in liver elasticity (elastography) ? Researchers implant the Trans-Duodenal Barrier to enclosed patients and follow up them till 4 weeks after explantation.
Participants will:
- Get the Trans-Duodenal Barrier as an implant for 6 moths
- Visit the clinic 3 times in the implant period and once for explant.
- Receive a telefon interview 4 weeks after explant
详细描述
Title of the study Clinical study to investigate the performance and safety of the Trans-Duodenal Barrier (LuST) Short title LuST EUDAMED Single Identification Number (SIN) or CIV-ID To be determined Sponsor Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim Tel georg.kaehler@transduodenal.com Manufacturer Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim Tel Test product Trans-Duodenal Barrier (TDB®) Risk class II b Study director Prof. Dr. Christoph Reißfelder, Director of the University Surgical Clinic Mannheim Other study centers
- Bamberg Social Foundation - Bamberg Clinic
- Charité Berlin
- University Hospital Bochum
- Dresden Municipal Hospital
- St. Georg Hospital, Leipzig
- University Hospital Leipzig
- University Hospital Mannheim
- University Hospital Würzburg Statistics and database management pfm medical expert gmbh, Wankelstraße 60, 50996 Cologne Project management
Study contact:
Prof. Dr. Georg Kähler Trans-Duodenal Concepts GmbH Tannhäuserring 93 68199 Mannheim georg.kaehler@transduodenal.com Study design National, multicenter, non-randomized, prospective CE marking study at eight trial sites in Germany.
Data on the use of TDB® will be collected over a period of 28 weeks. The focus here is on the performance of the Trans-Duodenal Barrier as measured by the long-term diabetes value HbA1c, patient satisfaction (patient-reported outcome), and the complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Obese patients with type 2 diabetes mellitus,
- •Age ≥ 18 years,
- •The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28),
- •The patient has been informed and all written consents from the patient are available.
排除标准
- •The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial.
- •The patient is unwilling or unable to follow postoperative instructions.
- •The patient has been placed in an institution by court order or official order (MPDG §27).
- •The patient lives more than 100 km from the treatment site.
- •Pregnancy.
- •The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.
研究组 & 干预措施
Treatment with endoscopic implant of the investigational device
The decive will be implanted under sedation with the help of a standard flexible gastroscope. By filling the ringlike ballons with 62 ccm saline solution it will be fixed at the gastric oulet.
After 6 months it will be removed by puncture and evacuation of the ballons and removal with a standard foreighn body forceps.
干预措施: endoscopic implant (Device)
结局指标
主要结局
Main Outcome Measure HbA1c reduction
时间窗: Improvement in 6 Month device implant time
The HbA1c reduction shall exceed 0,8 in average
Wight control
时间窗: Outcome after 6 months device implant time
Excessive Body Wight reduction in device implant time
次要结局
- Safety of the Trans-Duodenal Barrier(between implant and 4 weeks after explant (6 months after implant))