ObesityPhase 2/3NCT05872932
Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment
A Phase 2/3 study testing gastric balloon implantation and botulinum toxin A injection in people with Obesity, run by Sebahattin Celik MD at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- gastric balloon implantation and botulinum toxin A injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2023to 30 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University Faculty of Medicine
Van, 65080
About this study
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- gastric balloon implantation, botulinum toxin A injection
- Keywords
- obesity, gastric balloon, botulinum toxin A, intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric balloon implantationProcedure or surgery
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 injectionProcedure or surgery
Also called Gastric balloon implantation 1 week after Botox injection
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
| Study group | Role | What they receive |
|---|---|---|
| Only gastric balloon | Experimental | 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. Receives: Procedure: gastric balloon implantation |
| sequential botulinum toxin A injection and then gastric balloon | Experimental | 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. Receives: Procedure: gastric balloon implantation; Procedure: botulinum toxin A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who develop intolerance and undergo balloon removal procedure
Number of patients who develop intolerance and undergo balloon removal procedure
Measured: 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
Measured: The questionnaire will be taken 1 week after the balloon placement
Nausea-vomiting and retching measured using Rhodes index of nausea-vomiting-retching(RİNVR)
Measured: The questionnaire will be taken 6 hours after intragastric balloon placement
Number of analgesics and muscle relaxants needed
Measured: First week after intragastric balloon placement
Weight loss
Measured: 6 months after intragastric balloon placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start30 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebahattin Celik MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebahattin Celik MD, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872932
- Sponsor's protocol ID
- 2023-15/03/1374
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Combined Botulinum Toxin A Injection and Gastric Balloon Implantation in Obesity Treatment
- ClinicalTrials.gov ID
- NCT05872932
- Acronym / sponsor ID
- 2023-15/03/1374
- Conditions
- Obesity
- Keywords
- obesity, gastric balloon, botulinum toxin A, intervention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Sebahattin Celik MDUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Only gastric balloon | Experimental | Procedure: gastric balloon implantationAfter 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. |
| sequential botulinum toxin A injection and then gastric balloon | Experimental | Procedure: gastric balloon implantation, Procedure: botulinum toxin A injectionAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric balloon implantationAfter diagnostic endoscopy if there is no any gastric pathology that would be contraindication for balloon placement a gastric balloon will be placed | Procedure or surgery | Only gastric balloon, sequential botulinum toxin A injection and then gastric balloon |
| botulinum toxin A injectionAlso: Gastric balloon implantation 1 week after Botox injectionAfter 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 | Procedure or surgery | sequential botulinum toxin A injection and then gastric balloon |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing gastric balloon implantation and botulinum toxin A injection in people with Obesity, run by Sebahattin Celik MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who develop intolerance and undergo balloon removal procedure (time frame: First 6 months after intragastric balloon placement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.