Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
NCT ID: NCT04274608
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
18 participants
INTERVENTIONAL
2020-01-01
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Arm
Patients in the intervention arm will receive 300units of Botulinum Toxin A (Botox; Allergan Inc., Irvine, Ca, USA) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 20 separate injections of 0.5ml each will be performed in a concentric ring 1cm apart. 10 injections will be performed into the body of the stomach, and 10 injections into the fundus, from the level of the CEJ and above
Patients will undergo a 12-week weight management program approximately 2 weeks after the injection of Botox.
Botulinum toxin type A
Intragastric injection of Botulinum toxin type A
Weight Management Program
12 week weight management program
Control Arm
Patients will undergo a 12-week weight management program.
Weight Management Program
12 week weight management program
Interventions
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Botulinum toxin type A
Intragastric injection of Botulinum toxin type A
Weight Management Program
12 week weight management program
Eligibility Criteria
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Inclusion Criteria
2. BMI \>32.5 (Class II obesity)
Exclusion Criteria
2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
3. Patients with known liver cirrhosis or known esophageal/gastric varices
4. Known eating disorders
5. Known major cardiovascular or pulmonary conditions
6. Previous gastric/bariatric surgery
7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
8. Known alcohol or drug abuse
9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product
21 Years
65 Years
ALL
Yes
Sponsors
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Tan Tock Seng Hospital
OTHER
Responsible Party
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Danson Yeo Xue Wei
Associate Consultant
Locations
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Tan Tock Seng Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TanTockSengH
Identifier Type: -
Identifier Source: org_study_id
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