跳至主要内容
临床试验/NCT03349021
NCT03349021已完成不适用

The Bougiecap; a New Method for Treatment of Benign Stenosis in GI Tract

University of Ulm4 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Efficient bougienage with BougieCap

研究概览

简要总结

Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.

详细描述

Benign stenosis in the GI tract are endoscopically treated by using Savary-Gilliard Dilators. This method, although sufficient in its interventional success, provides only haptic control and often requires wire guidance or X-ray imaging for monitoring the position of the stenosis, the dilator and the dilation process.

To guarantee the missing optical feedback and enhance the intraprocedural control a conical, clear cap was developed. This single use device is attachable to the front end of an endoscope and provides direct visual evaluation of the mucosal damage and progress of the Bougienage, making x-ray imaging obsolete while resulting in an effective dilation. For the bougienage treatment, the endoscope with the cap on top is inserted into the patient's GI tract and aimed at the stenosis. By pushing the endoscope forward the cone shaped cap expands the mucosal diameter by conversion of longitudinal to radial force vectors. Lateral and frontal openings allow suction and flush during procedure.

The clear tapering cap is now to be tested for ist technical feasibility and ability to improve patients' quality of life following treatment. Therefore a quality of life questionnaire (Swal QoL) evaluating the patients' dysphagia is done right before and two weeks after the bougienage and an effective dilation is proved by being able to pass the stenosis with the endoscope after the treatment.

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

入选标准

  • benign Stenosis of the esophagus
  • indication for endoscopic treamtent of stenosis

排除标准

  • no informed consent
  • malignancy based Stenosis
  • no indication for endoscopic treamtent

研究组 & 干预措施

Bougiecap

Experimental

Treatment with Bougiecap instead of Savary Bougie

干预措施: Bougiecap (Device)

结局指标

主要结局

Efficient bougienage with BougieCap

时间窗: Day 0 (directly) after endoscopy

To measure the effect of bougienage a passage with the endoscope should be possible.after Treatment with the BougieCap (5mm Endoscope, 10mm endoscope)

次要结局

  • Qol dysphagia(Day 0 before endoscopy and Day14 after treatment)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Meining

Head of Endoscopy

University of Ulm

研究点 (4)

Loading locations...

相似试验