Status:
UNKNOWN
Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
Lead Sponsor:
Tan Tock Seng Hospital
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). O...
Eligibility Criteria
Inclusion
- Age 21 to 65yrs old
- BMI \>32.5 (Class II obesity)
Exclusion
- Pregnancy or lactation
- Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
- Patients with known liver cirrhosis or known esophageal/gastric varices
- Known eating disorders
- Known major cardiovascular or pulmonary conditions
- Previous gastric/bariatric surgery
- Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
- Known alcohol or drug abuse
- Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04274608
Start Date
January 1 2020
End Date
July 1 2022
Last Update
February 18 2020
Active Locations (1)
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1
Tan Tock Seng Hospital
Singapore, Singapore, 308433