EndoZip System vs Apollo ESG for Obesity
(ESG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods to help people with obesity lose weight: the EndoZip system and the Apollo ESG procedure. Both treatments use endoscopic suturing, which involves stitching the stomach internally to reduce its size. The goal is to determine the effectiveness of each method in aiding weight loss for those unsuccessful with non-surgical approaches. Candidates may be suitable if they have struggled with obesity, have a BMI over 30, and are open to significant lifestyle changes. As an unphased trial, this study offers a unique opportunity to explore innovative weight loss methods before they become widely available.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but certain medications like high-dose aspirin, anti-inflammatory agents, anticoagulants, and gastric irritants are not allowed. If you are on these or other specified medications, you may need to stop or adjust them.
What prior data suggests that these procedures are safe for obese patients?
Research has shown that the EndoZip System is safe for people. An initial study on humans demonstrated its safe use in treating obesity. Another study confirmed its safety and effectiveness in aiding weight loss. Early results showed an average weight loss of 11.4% after twelve months, indicating good tolerance.
The Apollo ESG has already received FDA approval for weight loss. This approval means its safety has been thoroughly studied, and it is generally considered safe to use.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they offer innovative approaches to tackling obesity with endoscopic techniques. The EndoZip System is unique because it automates the suturing process to create internal gastric segmentations, potentially increasing precision and efficiency compared to manual methods. On the other hand, the OverStitch Endoscopic Suturing System acts as an active comparator with its established manual suturing method. Both treatments aim to provide less invasive alternatives to traditional bariatric surgery, offering potential benefits in recovery time and overall patient experience.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that the EndoZip System, a treatment in this trial, helps people with obesity lose weight. In one study, participants lost an average of 11.4% of their total body weight after 12 months. Another study reported a weight loss of 13.21% over the same period. Additionally, 54% of patients with high blood pressure experienced improvements. The Apollo ESG procedure, another treatment option in this trial, uses a manual stitching technique in the stomach and has demonstrated similar success in promoting weight loss. Both treatments show promise in helping people lose weight and improve related health conditions.23567
Are You a Good Fit for This Trial?
This trial is for adults aged 21-65 with a BMI between 30 and 50 who haven't succeeded in losing weight through non-surgical methods. They must be willing to follow strict diet and lifestyle changes, attend regular follow-ups, and complete health questionnaires. Women must use birth control if they can have children. People with well-controlled hypertension or type II diabetes may join but not those on insulin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either the EndoZip or Apollo ESG procedure for weight reduction
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Apollo ESG
- EndoZip System
Trial Overview
The study compares two procedures for obesity treatment: the EndoZip System versus the Apollo ESG (Endoscopic Suturing System). It aims to see which one is more effective and safe in helping obese patients lose weight when traditional methods fail.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach.
Description: The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nitinotes Surgical Ltd.
Lead Sponsor
Citations
results from a prospective multicenter study (with video)
In this study, the EndoZip procedure induced a mean %TBWL of 13.21% and %EWL of 51.4% at 12 months. The results observed are similar to the ...
Interim Clinical Results for EndoZip™ Presented at IFSO ...
An average total body weight loss (%TBWL) of 11.4% ± 1.1 at twelve months. 54% of patients with hypertension showed improvements in blood ...
Emerging Trends in Endoscopic Bariatric Therapies
At six months, median weight loss was 13.8 kg in Group B vs. 7.9 kg in Group A (p < 0.001), BMI reduction was 4.9 vs. 3.13 (p < 0.001), and body ...
Comparing the Efficacy and Safety of the EndoZip System ...
The device is intended to be used in adult patients with obesity who have a body mass index (BMI) of 30-40 50 kg/m2 and who have not been able to lose weight or ...
Automatic endoscopic gastroplasty for the treatment of ...
Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and ...
Novel Endoscopic Suturing for Obesity: First-in-Human Study
Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising.
Safety and performance evaluation of the automated ...
In this article we describe the animal safety data and histology results of a head to head study of the automated helical suturing system, the EndoZip, versus ...
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