Endoscopic Sleeve Gastroplasty for Obesity

Overseen By Abigail A Stromme

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, NSAIDs, Anticoagulants, others

Disqualifiers: Gastric surgery, Ulcers, Varices, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a procedure called Endoscopic Sleeve Gastroplasty (ESG) to determine its safety and effectiveness in weight loss. It targets obese patients with ulcerative colitis who plan to undergo or have already undergone partial colon removal and are considering further surgery. The trial employs the Apollo Endoscopic Suture System to perform ESG. Candidates with a body mass index (BMI) between 30 and 50 for at least six months, who are willing to follow a specific diet and behavior plan, may be suitable participants. As an unphased trial, this study provides a unique opportunity to investigate a novel weight-loss procedure tailored to specific health needs.

Will I have to stop taking my current medications?

The trial requires that you avoid using weight loss medications, supplements, or herbal preparations. If you are using corticosteroids at a dose greater than 5 mg daily or anti-inflammatory agents like non-steroidal medications or anticoagulants, you must be under medical supervision. The protocol does not specify other medication restrictions.

What prior data suggests that the Endoscopic Sleeve Gastroplasty is safe for weight loss in obese patients?

Research has shown that the Apollo Endoscopic Suture System, used in Endoscopic Sleeve Gastroplasty (ESG), has been generally well-received. Patients undergoing this procedure have experienced positive outcomes, indicating its safety when performed by trained professionals.

Although every medical procedure carries some risk, previous studies have reported no major safety concerns with the Apollo system. Individual experiences may vary, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Endoscopic Sleeve Gastroplasty (ESG) for obesity because it offers a less invasive alternative to traditional bariatric surgeries like gastric bypass or sleeve gastrectomy. Unlike these surgical procedures, ESG uses an endoscopic method to reduce the size of the stomach without any external incisions, which can lead to fewer complications and a quicker recovery time. This minimally invasive approach not only targets weight loss but also encourages a healthier lifestyle through a structured post-procedure diet and lifestyle plan, potentially leading to better long-term outcomes.

What evidence suggests that Endoscopic Sleeve Gastroplasty is effective for weight loss in obese patients?

Research shows that Endoscopic Sleeve Gastroplasty (ESG), which participants in this trial will undergo, helps people with obesity lose weight. Studies have found that ESG can reduce the stomach size by 70-80%, leading to significant weight loss. Patients often feel full sooner and eat less, aiding in weight management. One major study found that ESG resulted in more weight loss after 52 weeks compared to lifestyle changes alone. This minimally invasive procedure doesn't involve removing any part of the stomach, making it a safer option for many. Overall, ESG is a promising treatment for obesity. ^{4 6 7 8 9}

Who Is on the Research Team?

Amanda M Johnson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for obese ulcerative colitis patients planning or having had colectomy, aiming for ileal pouch anal anastomosis. They must have a BMI between 30-50 kg/m2, be willing to follow diet and lifestyle changes, attend scheduled visits, and provide consent. Women should use birth control if of childbearing potential.

Inclusion Criteria

Willing to adhere to the diet and behavior modifications required for ESG

I have ulcerative colitis and am planning or have had a colectomy for a future 3-stage IPAA surgery.

I am a woman who cannot become pregnant or will use birth control and have a negative pregnancy test.

Exclusion Criteria

Alcohol or drug addiction

I have a large hiatal hernia with severe acid reflux.

I am taking more than 5 mg of corticosteroids daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endoscopic Sleeve Gastroplasty (ESG) Procedure

Participants undergo Endoscopic Sleeve Gastroplasty (ESG) followed by a 6-week transitional diet

6 weeks

Lifestyle Intervention

Participants start a lifestyle intervention following the transitional diet

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of peri-operative complications and weight loss

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Apollo Endoscopic Suture System
• Lifestyle Intervention

Trial Overview The study tests the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) versus only diet and lifestyle counseling in weight loss among obese ulcerative colitis patients before or after colectomy surgery.

How Is the Trial Designed?

Group I: Endoscopic Sleeve Gastroplasty (ESG) Experimental Treatment 2 Interventions

Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Apollo Endoscopic Suture System is already approved in United States, European Union for the following indications:

Approved in United States as Apollo ESG / OverStitch NXT for:

• Endoscopic Sleeve Gastroplasty (ESG)
• Transoral Outlet Reduction (TORe)

Approved in European Union as Apollo ESG / OverStitch NXT for:

• Endoscopic Sleeve Gastroplasty (ESG)
• Transoral Outlet Reduction (TORe)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Endoscopic suturing with the OverStitch system was successfully performed on 13 patients with upper gastrointestinal leaks, achieving a 100% interventional success rate in closing the leaks.

The technique was found to be safe, with no serious complications reported, and it is particularly effective for patients with large leaks who have not undergone prior treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract. Chon, SH., Toex, U., Plum, PS., et al.[2021]

Endoscopic sleeve gastroplasty using the Apollo method is a safe and effective weight loss intervention, with no major complications reported in a study of 55 patients over 6 months.

Patients experienced an average weight loss of 18.9 kg and a 55.3% reduction in excess weight, demonstrating significant efficacy when combined with dietary and psycho-behavioral support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. López-Nava Breviere, G., Bautista-Castaño, I., Fernández-Corbelle, JP., et al.[2017]

The OverStitch devices demonstrated a 100% technical feasibility rate and a high technical success rate of 99.3% in endoscopic suturing across 137 patients, indicating their reliability for various applications.

The overall clinical success rate was 89%, with particularly high success in treating mucosal defects (100%) and perforations (94.7%), suggesting that OverStitch technology is effective for resolving clinical issues, especially for fistulas smaller than 1 cm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry. Maselli, R., Palma, R., Traina, M., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) using the OverStitch Sx™ device was found to be a safe procedure, with only 1.04% of patients experiencing post-procedural complications and no major intra-procedure adverse events reported among 191 patients.

The procedure resulted in significant weight loss, with an average total weight loss of 22.4% at 6 months and 18.7% at 12 months, indicating its efficacy as a minimally invasive treatment for primary obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. Manos, T., Costil, V., Karsenty, L., et al.[2022]

The Endoscopic Sleeve Gastroplasty using OverStitch was successfully performed on a male patient with a BMI of 35.17 kg/m2, demonstrating its feasibility and safety with no bleeding or complications during the procedure.

The procedure took only 50 minutes and resulted in mild abdominal pain, with the patient able to accept a liquid diet afterward, indicating a quick recovery and minimal discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ENDOSCOPIC SLEEVE GASTROPLASTY - MINIMALLY INVASIVE THERAPY FOR PRIMARY OBESITY TREATMENT. Galvão-Neto, MD., Grecco, E., Souza, TF., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is a minimally invasive outpatient procedure that reduces stomach volume to aid in weight loss, but it carries risks of serious complications.

In a reported case, a patient experienced severe complications including ischemia, perforation, and peritonitis immediately after the procedure, highlighting the need for careful monitoring and management of potential risks associated with ESG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty Leading to Gastric Ischemia and Perforation. Stolz, MP., Gibson, BH., Vassy, WM.[2023]

The Overstitch endoscopic suturing system was successfully used in 5 patients over 6 months for two main applications: stent fixation to prevent migration and outlet reduction after gastric bypass, achieving technical success in all cases.

All patients experienced clinical recovery, with significant weight loss in those who underwent outlet reduction, demonstrating the system's safety and effectiveness in managing gastrointestinal disorders where other treatments may not be sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of common patologies with a new suturing system. González-Panizo-Tamargo, F., Rojas-Sánchez, Á., Miranda-García, P., et al.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468448124001772

Interlocking endoscopic sleeve gastroplasty with next- ... Endoscopic sleeve gastroplasty (ESG) is a minimally invasive, organ-preserving, and cost-effective weight loss procedure designed for patients who are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9276350/

Endoscopic sleeve gastroplasty: a narrative review on ... This article summarizes and appraises both traditional and novel data regarding ESG as a treatment for obesity and overweight.

3. bostonscientific.com bostonscientific.com/en-EU/medical-specialties/bariatric-endoscopy/endoscopic-sleeve-gastroplasty.html

Endoscopic Sleeve Gastroplasty (ESG) The ESG procedure reduces stomach volume by 70-80% and delays gastric emptying, resulting in earlier satiety and weight loss. One major clinical study showed ...

4. gi.org gi.org/journals-publications/ebgi/kolb_chiang_feb2023/

Endoscopic Sleeve Gastroplasty Is Effective for Patients ... Outcomes: The primary outcome was excess weight loss (EWL) at 52 weeks with ESG compared to lifestyle intervention alone. EWL was calculated as: ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232544.pdf

September 18, 2023 Boston Scientific Inc. James Shene ... The Apollo ESG NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210045.pdf

DEN210045 decision summary - accessdata.fda.gov The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01662024

Endoscopic Suturing for Primary Obesity Treatment The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue ...

8. bostonscientific.com bostonscientific.com/content/dam/elabeling/endo/apollo_elabeling/51931761-01A_OverStitch_NXT_IFU_US_EN_s.pdf

OverStitch NXT™ The OverStitch NXT Endoscopic Suturing System is used to perform Transoral. Outlet Reduction (TORe) (applying 1 or 2 suture-anchors to reduce the size of the ...

9. igiejournal.org igiejournal.org/article/S2949-7086(24)00132-8/fulltext

Efficacy and safety of over-the-scope endoscopic suturing ... The primary outcomes were technical success and efficacy of instrument use for patients undergoing procedures with the OverStitch system.