Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study

Launched by USGI MEDICAL · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called the POSE2.0 study, is investigating a new, less invasive weight loss procedure for people with obesity. The goal is to see if this procedure, which uses special tools to place sutures in the stomach, can help people lose weight more effectively when combined with a balanced diet and exercise, compared to just following a diet and exercise plan alone. The study is being conducted at multiple locations and aims to evaluate the safety and effectiveness of this approach.

To participate in the trial, candidates need to be between 22 and 65 years old, have a Body Mass Index (BMI) between 30 and 50, and have previously tried losing weight with diet and exercise without success. Participants will also need to commit to following specific dietary and exercise guidelines throughout the study. If you are eligible and choose to join, you can expect to undergo the incisionless procedure and attend regular follow-up visits to monitor your progress. It's important to note that the study is not yet recruiting participants, so there will be more information available soon for those interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form.
• • 2. Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
• • 3. Subjects between the ages of 22-65 years.
• • 4. History or failure with non-surgical weight-loss methods.
• • 5. If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
• • 6. Have a Body Mass Index (BMI) of ≥ 30 and ≤ 50 kg/m².
• • 7. Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
• • 8. Agrees to forego any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
• • 9. Have not taken any prescription or over-the-counter weight loss medications in the last 6 months, with exception of medications used to manage T2D so long as the subject has been on a stable dose and weight has persisted.
• • 10. Residing within a reasonable distance from the Investigator's treating office (\~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits.
• Exclusion Criteria:
• • 1. History of or intra-operative evidence of prior bariatric, gastric or esophageal surgery.
• • 2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• • 3. Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.
• • 4. Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
• • 5. Pancreatic insufficiency/disease.
• • 6. History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g., esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• • 7. Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in the next 12 months.
• • 8. History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
• • 9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
• • 10. Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
• • 11. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• • 12. Active gastric erosion, lesion, or gastric/duodenal ulcer.
• • 13. History of or current platelet or coagulation dysfunction, such as hemophilia.
• • 14. History or present use of insulin or insulin derivatives for treatment of diabetes.
• • 15. Patients with type II diabetes mellitus on oral agents (not injectables) with HgA1c \> 9 at the time of enrollment.
• • 16. Active smoker or someone who has been a smoker in the 6 months leading up to the study.
• • 17. Portal hypertension and/or varices.
• • 18. Patient has a history of drug or alcohol abuse or positive at screening for drug use.
• • 19. Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
• • 20. Present or history of psychosis, bipolar disease, obsessive-compulsive disorder, binge eating, and/or other eating disorders after pre-enrollment history and medical /psychological assessment.
• • 21. Beck Depression Inventory (Short) Score ≥ 12, and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
• • 22. Patient score \>2 in any of the identified symptoms in the nausea/vomiting or bloating/distension domains on the Gastroparesis Cardinal Symptom Index (GCSI).
• • 23. Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
• • 24. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH \>5.0 U/ml).
• • 25. Present or history of chronic abdominal pain.
• • 26. Participating in another clinical study that could compromise compliance with the POSE2.0 study (must be cleared with investigator and USGI Medical).
• • 27. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• • 28. Any other medical condition that would not permit elective endoscopy such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease, and/or physician's assessment that the subject is not an appropriate candidate.