EUCTR2015-004391-29-ES
Active, not recruiting
Phase 1
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 sites60 target enrollmentFebruary 3, 2016
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Morbid obesity
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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