跳至主要内容
临床试验/EUCTR2015-004391-29-ES
EUCTR2015-004391-29-ES进行中(未招募)1 期

Effectiveness of intragastric injection of botulinum toxin by endoscopy in obese patients in surgical waiting list. Study InBoTox - InBoTox

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)0 个研究点目标入组 60 人开始时间: 2016年2月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Male or female
  • 2. Age 18-65 years
  • 3. BMI> 40 or BMI> 35 with comorbidities
  • 4. Waiting list for bariatric surgery between 6 and 12 months before the intervention.
  • 5. Willingness to attend scheduled visits
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • 1. Obesity of endocrine origin.
  • 2. Recent anti-obesity 2 treatment (<3 months).
  • 3. myopathy, known neuromuscular or neurological disease
  • 4. Severe Psychopathology contraindicating procedure
  • 5. active gastrointestinal disease (esophagitis, peptic ulcer, cancer, etc., already diagnosed).
  • 6. History of gastric surgery.
  • 7. previous botulism.
  • 8. dysfunction of gastrointestinal motility because of opioids, anticholinergics or other drugs.
  • 9. known intolerance upper endoscopy.
  • 10. Pregnant or breast-feeding.

研究者

发起方
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

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