Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study

Last updated: April 5, 2024
Sponsor: True You Weight Loss
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Endoscopic Sleeve Gastroplasty

Hybrid Argon Plasma Coagulation

Clinical Study ID

NCT05870943
RCT-001
  • Ages 21-65
  • All Genders

Study Summary

The purpose of this research is to evaluate the clinical safety, durability, and weight loss outcomes of the hybrid argon plasma coagulation + endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional endoscopic sleeve gastroplasty (ESG) alone. ESG was proven to be feasible in human subjects in 2013 and since then has become the most commonly performed endoscopic bariatric remodeling procedure. However, this procedure may be enhanced with the addition of the hybrid argon plasma coagulation (HAPC) technique, leading to enhanced weight loss, durability, and metabolic benefits. Argon plasma coagulation (APC) is a method of non-contact thermal hemostasis initially created to assist in inducing hemostasis utilizing a high-frequency current to the targeted area. This is a validation study of a pilot randomized control trial which will evaluate the safety, durability, and effects on weight loss of the combined HAPC-ESG approach when compared to traditional ESG alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 21-65
  2. BMI ≥ 30 and ≤40 kg/m²
  3. Willingness to comply with the substantial lifelong dietary restrictions required bythe procedure.
  4. History of failure with non-surgical weight-loss methods.
  5. Willingness to follow protocol requirements, including signed informed consent,routine follow-up schedule, completing laboratory tests, and completing dietcounseling.
  6. Residing within a reasonable driving distance from the investigator's office (Cary,NC) and able to travel to the investigator to complete all routine follow-up visits asapplicable
  7. Ability to give informed consent.
  8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized)must agree to use adequate birth control methods.
  9. Reliable access to wi-fi and/or internet services.

Exclusion

Exclusion Criteria:

  1. History of foregut or gastrointestinal (GI) surgery (except uncomplicatedcholecystectomy or appendectomy).
  2. Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesiveperitonitis or known abdominal adhesions.
  3. Prior open or laparoscopic bariatric surgery.
  4. Prior surgery of any kind on the esophagus, stomach, or any type of hiatal herniasurgery.
  5. Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C orD) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer,or specific inflammatory disease such as Crohn's disease or celiac disease.
  6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastricvarices, congenital or acquired intestinal telangiectasis, or other congenitalanomalies of the gastrointestinal tract such as atresias or stenoses.
  7. Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinalmetaplasia), history of familial and nan-familial adenomatous syndromes.
  8. A gastric mass or gastric polyps > 1 cm in size.
  9. A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm orsevere or intractable gastro-esophageal reflux symptoms.
  10. A structural abnormality in the esophagus or pharynx such as a stricture ordiverticulum that could impede passage of the endoscope.
  11. Achalasia or any other severe esophageal motility disorder
  12. Severe coagulopathy.
  13. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood ofrequiring insulin treatment in the following 12 months or a HgbA1C≥9.
  14. Subjects with any serious health condition unrelated to their weight that wouldincrease the risk of endoscopy.
  15. Chronic abdominal pain.
  16. Motility disorders of the GI tract such as gross esophageal motility disorders,gastroparesis or intractable constipation.
  17. Hepatic insufficiency or cirrhosis.
  18. Use of an intragastric device prior to this study due to the increased thickness ofthe stomach wall preventing effective suturing.
  19. Active psychological issues preventing participation in a life-style modificationprogram as determined by a psychologist.
  20. Patients unwilling to participate in an established medically supervised diet andbehavior modification program, with routine medical follow-up.
  21. Patients receiving daily prescribed treatment with high dose aspirin (> 81mg daily),anti-inflammatory agents, anticoagulants, or other gastric irritants.
  22. Patients who are unable or unwilling to take prescribed proton pump inhibitormedication.
  23. Patients who are pregnant or breast-feeding.
  24. Patients currently taking weight-loss medications or other therapies for weight losswithin the prior 6 months.
  25. Subjects with severe cardiopulmonary disease or other serious organic disease whichmight include known history of coronary artery disease, myocardial infarction withinthe past 6 months, poorly controlled hypertension, required use of NSAIDs.
  26. Subjects taking medications on specified hourly intervals that may be affected bychanges to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
  27. Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
  28. Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary arterydisease.
  29. Pre-existing respiratory disease such as moderate or severe chronic obstructivepulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
  30. Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus,scleroderma) or immunocompromised.
  31. Specific diagnosed genetic disorder such as Prader Willi syndrome.
  32. Eating disorders including night eating syndrome (NES), bulimia, binge eatingdisorder, or compulsive overeating.
  33. Known history of endocrine disorders affecting weight such as uncontrolledhypothyroidism.
  34. At the discretion of the PI for subject safety
  35. If minority inclusion population target of 10% has not been reached by the 90%enrollment mark (example 43 of 48 subjects), the remaining enrollments will bereserved for minority subjects (example 5 of 48 subjects).

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Endoscopic Sleeve Gastroplasty
Phase:
Study Start date:
May 18, 2023
Estimated Completion Date:
May 31, 2025

Study Description

Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. Argon Plasma Coagulation (APC) is a method of non-contact thermal hemostasis which utilizes a high-frequency current applied to the target tissue through an argon plasma jet to induce hemostasis and a homogenous surface coagulation with a limited depth of penetration. APC is a widely used therapy in the luminal digestive tract to provide non-contact, targeted thermal injury for mucosal ablation and may therefore allow for a greater submucosal component of healing between tissue plications and, consequently, greater durability of the gastroplasty. Enhanced fibrosis along the site of endoscopic plications with the addition of APC could decrease the incidence of weight regain in patients undergoing ESG and capitalize on the metabolic benefits of gastric mucosal revitalization reported with APC alone. In this study, the investigators propose to evaluate the durability of endoscopic plications, weight loss outcomes, and improvements in obesity related co-morbidities for the combined hybrid argon plasma coagulation plus endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional ESG. Investigators hypothesize that HAPC-ESG will provide greater durability of the gastroplasty construct than traditional ESG. This is a single-center, randomized, single-blinded clinical trial evaluating the efficacy and safety of HAPC-ESG for weight loss and improvement in obesity-related co-morbidities compared to ESG alone. The study population includes adult patients who are seeking ESG at True You Weight Loss in Cary, NC with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical management.

Connect with a study center

  • True You Weight Loss

    Cary, North Carolina 27513
    United States

    Site Not Available

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