Gastric Balloon for Obesity

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Gastrointestinal disease, Psychological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the gastric balloon treatment for obesity?

Research shows that the gastric balloon is a temporary, non-surgical treatment that helps people lose weight. Studies have found it effective for weight reduction in obese and extremely obese patients, as well as in overweight individuals with conditions like diabetes and high blood pressure. ^{1 2 3 4 5}

How does the gastric balloon treatment for obesity differ from other treatments?

The gastric balloon is a temporary, nonsurgical treatment for obesity that involves placing an inflatable balloon in the stomach to help patients lose weight, especially those who have not succeeded with other methods or are preparing for surgery. Unlike more invasive bariatric surgeries, it is less hazardous but is primarily used as a preoperative step rather than a standalone solution for long-term weight loss. ^{1 6 7 8 9}

What is the purpose of this trial?

Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.

Research Team

Roberto Gugig, MD

Principal Investigator

Stanford University

Monique T Barakat, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for obese or morbidly obese teens aged 14-19 with a BMI >3.5 SD who can commit to regular support sessions and lifestyle changes. It's not for those with significant psychological disorders, past stomach surgeries, large hiatus hernias, severe reflux symptoms, inflammatory GI diseases, or congenital anomalies.

Inclusion Criteria

I can attend sessions every 2 to 4 weeks and follow lifestyle advice.

I am a teenager aged 14-19 and clinically very overweight.

Exclusion Criteria

I have had serious inflammation or ulcers in my digestive system.

I have had surgery on my esophagus or stomach, or I have a history of blocked intestines.

I have a large hiatus hernia or a smaller one with severe acid reflux.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an endoscopically placed intra-gastric balloon combined with behavioral support for weight loss

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Gastric Balloon

Trial Overview The study tests the effectiveness of an endoscopically placed gastric balloon in combination with behavioral support to help overweight adolescents lose weight and improve their health.

Participant Groups

Group I: gastric ballon placement Experimental Treatment 1 Intervention

will receive gastric balloon placed via endoscopy

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study of 190 obese patients undergoing gastric balloon therapy, the average weight loss was 21.2 kg after 6 months, indicating significant efficacy in promoting weight loss for morbidly obese individuals.

The procedure demonstrated a high safety profile, with only minor complications occurring in 2% of cases and no major complications or mortality, making it a viable option for initial obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative weight reduction using the intragastric balloon. Göttig, S., Weiner, RA., Daskalakis, M.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Preoperative weight reduction using the intragastric balloon. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[The gastric balloon--a retrospective cohort analysis of 634 patients]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The use of an improved intragastric balloon technique to reduce weight in pre-obese patients--preliminary results. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Analysis of safety and efficacy of intragastric balloon in extremely obese patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience. [2021]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Is there any role for gastric balloon in obesity treatment?]. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Intragastric balloon treatment for obesity: results of a large single center prospective study. [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

Intragastric balloon placement for the management of obesity: improving patient selection. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

[Treatment of obesity with gastric balloon]. [2007]