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OpenTrials
Completed

NCT Number: NCT05872932

Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yuzuncu Yil University Faculty of Medicine

Van, 65080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with body mass index over 30
  • patients who have been on a diet and have done sports at least for 6 month and yet could not lose weight.
  • 18-65 years old patients

Exclusion criteria

  • patients diagnosed with peptic ulcer
  • untraceable patients after injection of botulinum toxin A
  • patients with no history of bariatric surgery or interventions
  • patients who do not retrieve balloon after 6 month or require repetitive implantations.

Treatment and study plan

gastric balloon implantation

Procedure

After diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed

botulinum toxin A injection

Procedure

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

Other names: Gastric balloon implantation 1 week after Botox injection

Primary outcomes

  1. Number of patients who develop intolerance and undergo balloon removal procedure

    Time frame: First 6 months after intragastric balloon placement

    Number of patients who develop intolerance and undergo balloon removal procedure

  2. Quality of life measured using SF-36 questionnaire

    Time frame: The questionnaire will be taken 1 week after the balloon placement

    The acute(1 week) time frame format of Short Form-36 questionnaire will be used to assess health-related quality of life

  3. 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

  4. Number of analgesics and muscle relaxants needed

    Time frame: First week after intragastric balloon placement

  5. Weight loss

    Time frame: 6 months after intragastric balloon placement

Sponsors and collaborators

Lead sponsor

Sebahattin Celik MD

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 24, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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