Intragastric Injections of Botox for the Treatment of Obesity
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Inclusion Criteria
- BMI > 35
- BMI > 35
Exclusion Criteria
- Known hypersensitivity to medication
- Neuro muscular disease
- Ulcus
- ...
- Known hypersensitivity to medication
- Neuro muscular disease
- Ulcus
- Pregnancy/brest feeding
- Previous side effects of botox injections
- Use of aminoglycoside antibiotics and/or spectinomycin lately
- Previous bariatric surgery
- Tendency for aspiration
- Dysphagia
- Previous cancer in GI-tract
- Reduced competence to consent
- Hypothyroidism
- Severe eating disorder
- Other obesity treatment last 12 months
Summary
- Conditions
- Obesity Morbid
- Obesity, Morbid
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Inclusion Criteria
- BMI > 35
- BMI > 35
Exclusion Criteria
- Known hypersensitivity to medication
- Neuro muscular disease
- Ulcus
- ...
- Known hypersensitivity to medication
- Neuro muscular disease
- Ulcus
- Pregnancy/brest feeding
- Previous side effects of botox injections
- Use of aminoglycoside antibiotics and/or spectinomycin lately
- Previous bariatric surgery
- Tendency for aspiration
- Dysphagia
- Previous cancer in GI-tract
- Reduced competence to consent
- Hypothyroidism
- Severe eating disorder
- Other obesity treatment last 12 months
Tracking Information
- NCT #
- NCT02035397
- Collaborators
- St. Olavs Hospital
- Investigators
- Principal Investigator: Bård Kulseng, MD, PhD Norwegian University of Science and Technology, Fac MH, IKOM
- Bård Kulseng, MD, PhD Norwegian University of Science and Technology, Fac MH, IKOM
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