A Phase 2/3 interventional study of gastric balloon implantation and botulinum toxin A injection in Obesity, sponsored by Sebahattin Celik MD. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Sebahattin Celik MD · Phase 2/3, Interventional, and Treatment
Obesity, which is defined as the accumulation of fat in the body to a degree that impairs health, is defined as a serious public health problem and it is estimated that 13% (approximately 650 million) of the entire world population is obese.
There are different methods in the fight against obesity, one of these methods is bariatric interventions. Although bariatric surgery is the most effective of these procedures, the tendency to endoscopic methods is increasing due to the surgical risk. Gastric balloon is the most common endoscopic method. In addition, gastric botox is among the methods used.
Health consequences of endoscopic interventions have been widely investigating and while gastric balloon recommended as safe and effective method, the situation for gastric botox is controversial.
Although it seems as gastric balloon is an office procedure and safely performed, especially the first week is difficult process for patients. It can also end with abdominal pain, nausea, retching, and eventually a process leading to premature removal of the balloon. In Italian study, Genco et al. reported that out of 2515 patients 11 patients (0.44%) balloon removed due to psychological intolerance. While the reported rate of early gastric balloon removal generally ranges from 0.44% to 16%, De Castro ML. et al. reported the early removal rate as 20%. While the complications related to the gastric balloon are as stated, problems such as nausea, vomiting and cramps after the gastric botox procedure are either not reported or not seen at all.
Therefore, we hypothesize that sequential endoscopic procedures (first botox application followed by gastric balloon placement) will reduce these early complications (abdominal pain, nausea, retching) and early removal of the gastric balloon.
The only study we have reached regarding combined therapy was done in Turkey. Kanlıöz M et al. reported that combining botox and balloon was found to be more effective in losing weight, but it was stated that it had more side effects. In this study, we think that the side effects may already be related to the balloon. As James A et al. stated in their experimental work, the effectiveness of botox is time dependent. It has been stated that the efficacy is optimal after 6 hours in injections to the pyloric region.The fact that the balloon was inserted in the same session, without waiting for enough time after the botox procedure to be effective, may have reduced the possible protective effect of the botox.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 131 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Sebahattin Celik MD is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
After analgesia endoscopy will be performed. After diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed. For first day standard medication will be provided. Starting from first hour until 1 week, patient nausea -vomiting and retching scores, re-admission to hospital, quality of life scores will be documented. After analgesia endoscopy will be performed. After diagnostic endoscopy if there is not any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed. For first day standard medication will be provided. Starting from first hour until 1 week, patient nausea -vomiting and retching scores, re-admission to hospital, quality of life scores will be documented.
Procedure: gastric balloon implantation
After analgesia endoscopy will be performed. After diagnostic endoscopy if there is not any gastric pathology that would be contraindication for Botox injection and balloon placement, 200 U of botulinum toxin A will be injected to the antrum and the fundus. After 24 hour or 1 week the second procedure (placement of gastric balloon) will be performed. And Starting from first hour until 1 week, patient's nausea-vomiting and retching scores, re-admission to hospital, quality of life scores will be documented.
Procedure: gastric balloon implantation · Procedure: botulinum toxin A injection
After diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed
After diagnostic endoscopy if there is no any gastric pathology that would be contraindication Botox injection and balloon placement, 200 U of Botox A will be injected to antrum and fundus. And 1 week later gastric balloon will be implanted
Also known as: Gastric balloon implantation 1 week after Botox injection
Number of patients who develop intolerance and undergo balloon removal procedure
Number of patients who develop intolerance and undergo balloon removal procedure
Time frame: First 6 months after intragastric balloon placement
Quality of life measured using SF-36 questionnaire
The acute(1 week) time frame format of Short Form-36 questionnaire will be used to assess health-related quality of life
Time frame: The questionnaire will be taken 1 week after the balloon placement
Nausea-vomiting and retching measured using Rhodes index of nausea-vomiting-retching(RİNVR)
Time frame: The questionnaire will be taken 6 hours after intragastric balloon placement
Number of analgesics and muscle relaxants needed
Time frame: First week after intragastric balloon placement
Weight loss
Time frame: 6 months after intragastric balloon placement
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Sebahattin Celik MD