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Clinical Trials/EUCTR2015-004391-29-ES
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

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.

Registry
who.int
Start Date
February 3, 2016
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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

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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