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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a gastric balloon, a device placed in the stomach, to aid weight loss in obese teens. The goal is to evaluate its effectiveness when combined with behavioral support to improve health. Teens aged 14-19 who are clinically obese and can attend regular support sessions might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in teen weight management.

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 prior data suggests that the gastric balloon is safe for adolescents?

Research has shown that the gastric balloon is generally safe for treating obesity. One study found that the balloon is safe for up to 12 months, with side effects similar to those in other studies. However, some research has identified more serious side effects in about 5.6% of people using the balloon, compared to 1.1% of those receiving standard care. This indicates that while risks exist, they are uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the gastric balloon for obesity because it offers a less invasive option compared to traditional weight loss surgeries like gastric bypass or sleeve gastrectomy. This treatment involves placing a balloon in the stomach via endoscopy, which does not require major surgery or permanent alteration of the digestive system. The balloon helps patients feel full sooner, potentially leading to significant weight loss without the risks and recovery time associated with surgical procedures. This makes it an appealing option for those seeking effective weight management with minimal downtime.

What evidence suggests that the gastric balloon is effective for obesity?

Research has shown that gastric balloons can help obese individuals lose weight. Studies have found that those using a gastric balloon can lose between 10.5% and 13.7% of their body weight. One study found that patients lost about 36.58% of their excess body weight. In some cases, patients lost 27.9% of their excess weight, significantly more than those who only followed a diet. However, some people may regain weight after the balloon is removed. Overall, the gastric balloon appears promising for effective weight loss when combined with behavioral support. Participants in this trial will have a gastric balloon placed via endoscopy to evaluate its effectiveness in weight loss. ^{3 5 6 7 8}

Who Is on the Research Team?

Roberto Gugig, MD

Principal Investigator

Stanford University

Monique T Barakat, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6505645/

Intragastric balloon treatment of obesity: Long-term results ... When assessing the long-term follow-up, years after the IGB removal (3.3±1.76 years), the vast majority of patients (78.7%) regained weight or resorted to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4917609/

Current status of intragastric balloon for obesity treatment - PMC Body weight loss. Results from previous studies indicated that the mean weight loss associated with intragastric balloon therapy ranged between 10.5 and 13.7 ...

3. mayoclinic.org mayoclinic.org/medical-professionals/endocrinology/news/intragastric-balloon-a-re-emerging-approach-for-obesity/mac-20430245

Intragastric balloon: A re-emerging approach for obesity The trial showed that patients with the dual balloon lost 27.9 percent of excess weight compared with excess weight loss of 12.3 percent in the diet group. Most ...

4. link.springer.com link.springer.com/article/10.1007/s11695-023-06953-0

Safety and Efficacy of 12-Month Intra-gastric Balloon ... This equated to 11.11% total body weight loss (TBWL) (IQR 6.67–16.45%) or 36.58% excess BMI loss (IQR 21.05–56.50%) (Table 3). Of the entire ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S204908012100087X

Intra-gastric balloons – The past, present and future In a meta-analysis conducted in 2008 involving 3608 patients the Orbera balloon resulted in a median %EWL of 32.1% (CI 26.9–37.4) and a median % total weight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10781818/

Safety and Efficacy of 12-Month Intra-gastric Balloon—Series ... The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354925/

Comparative Efficacy and Long-Term Outcomes of Intragastric ... Long-term outcomes revealed durable weight maintenance over six to 60 months (mean 8.01 kg, 95% CI 4.93-11.09; I² = 60.55%; BMI reduction: 4.96 ...

8. gastrojournal.org gastrojournal.org/article/S0016-5085(21)00477-7/fulltext

AGA Clinical Practice Guidelines on Intragastric Balloons ... More serious adverse outcomes were observed in patients who received IGB therapy (5.6%) compared with those in the SOC groups (1.1%) (RR, 3.07; 95% CI, 1.16–8. ...