Endoscopic Sleeve Gastroplasty for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Endoscopic Sleeve Gastroplasty (ESG) is a safe and effective method for helping adolescents with obesity lose weight. Instead of traditional surgery, participants will undergo the ESG procedure to reduce stomach size. Researchers will also assess whether this leads to improved overall health and quality of life. Adolescents who have been managing their weight for at least six months and have conditions like type 2 diabetes or sleep apnea (difficulty breathing during sleep) are good candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in adolescent obesity treatment.
Do I have to stop taking my current medications for the trial?
The trial requires participants to stop taking any prescription or over-the-counter weight loss medications and weight loss/appetite suppressing dietary supplements during the study. If you are on medications known to cause significant weight changes, you may not be eligible to participate.
What prior data suggests that the Apollo Endosurgery ESG System is safe for adolescents with obesity?
Research shows that Endoscopic Sleeve Gastroplasty (ESG) is generally safe for treating obesity. Studies have found that serious side effects occur in only about 2% of patients, with major issues related to the procedure or the device being rare. Most people tolerate the procedure well, and it effectively aids in weight loss and improves health problems related to obesity. Some studies indicate that even patients with severe obesity did not experience significant short-term safety issues after ESG. Overall, ESG appears to be a well-tolerated and safe option for managing weight.12345
Why are researchers excited about this trial?
Endoscopic Sleeve Gastroplasty (ESG) is unique because it offers a minimally invasive approach to treating obesity, unlike traditional surgical options like gastric bypass or sleeve gastrectomy. ESG uses an endoscope, a flexible tube inserted through the mouth, to reduce the stomach's size by internally suturing it, which means no external incisions are needed. This technique not only minimizes the risk of complications but also typically results in a shorter recovery time. Researchers are excited about ESG because it could provide an effective weight loss solution with fewer risks and faster recovery compared to more invasive surgeries.
What evidence suggests that the Endoscopic Sleeve Gastroplasty procedure is effective for obesity?
Research shows that Endoscopic Sleeve Gastroplasty (ESG), the treatment under study in this trial, aids in weight loss. Studies have found that individuals can lose 13% to 20% of their body weight within a year after the procedure. ESG also improves obesity-related health issues, such as diabetes and high blood pressure. Long-term evidence suggests that weight loss from ESG can last up to 10 years. The procedure is considered safe, with few complications. Overall, ESG offers a promising option for those seeking significant weight loss and health improvement.12567
Who Is on the Research Team?
Michael Manfredi, MD
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
This trial is for obese adolescents aged 12-17 who have tried supervised diets and exercise programs. They must be significantly overweight according to CDC growth curves, possibly with related health issues like diabetes or sleep apnea. Girls can't be pregnant and must agree not to get pregnant during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Endoscopic Sleeve Gastroplasty (ESG) procedure under general anesthesia, followed by overnight hospital admission for recovery and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including physical examinations and surveys about side effects and quality of life
Long-term follow-up
Evaluation of the effectiveness of ESG in long-term reduction of weight and improvements in obesity-related co-morbidities
What Are the Treatments Tested in This Trial?
Interventions
- Endoscopic Sleeve Gastroplasty (ESG) Procedure
Trial Overview
The trial tests the Apollo Endosurgery ESG System, a non-surgical procedure that reduces stomach volume under general anesthesia. It aims to see if this method is safe for weight loss in teens and how it affects their long-term health and quality of life.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Citations
Outcomes of Endoscopic Sleeve Gastroplasty
ESG has demonstrated effectiveness in achieving weight loss and improving obesity-related comorbidities while maintaining a favorable safety ...
2.
journals.lww.com
journals.lww.com/ajg/fulltext/2024/10001/s2063_ten_year_outcomes_of_endoscopic_sleeve.2064.aspxS2063 Ten-Year Outcomes of Endoscopic Sleeve ...
The primary outcome was weight loss at 10 years after the procedure reported as percent total body weight loss (%TBWL). The safety and durability of ESG ...
Endoscopic Sleeve Gastroplasty Is Effective for Patients ...
Of the 60 patients who achieved their goal weight of >25% EWL at 1 year, 41 (68%) had sustained weight loss using the same definition at 2 years ...
4.
gastroendonews.com
gastroendonews.com/Endoscopy-Suite/Article/03-25/Long-Term-Data-on-ESG-Show-Durable-Weight-Loss-at-10-Years/76364Long-Term Data on ESG Show Durable Weight Loss at 10 ...
New research with a decade's worth of data indicates that endoscopic sleeve gastroplasty yields long-term weight loss without adjuvant ...
Weight regain after endoscopic sleeve gastroplasty
Subsequent prospective studies have shown a total body weight loss (TBWL) at 12 months after ESG ranging from 13% to 20% and an adverse events ratio of 2%. A 5- ...
ANALYSIS OF SAFETY OF ENDOSCOPIC SLEEVE ...
There were no significant differences in any short-term safety outcome for “super obese” patients who underwent ESG (Table 1). Moreover, there were no ...
P279 Safety and outcomes of endoscopic sleeve ...
13 patients have at least 6 months post procedure follow up. Average total body weight loss at 6, 12 and 24 months was 17.78%, 36% and 26.7% respectively.
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