Incisionless Suture Plications in a POSE2.0 Obesity Study

Официальное название

Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study (The INSPIRO Study)

Обзор

This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).

Подробное описание

This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).

Вмешательства

• Устройство POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
  POSE2.0 (g-Cath EZ snowshoe suture anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program

Первичные конечные точки

• Percentage of total body weight loss (%TBWL) following randomization [Срок оценки: 12 months]
• Responder rate of at least 50% in the POSE2.0 treatment group [Срок оценки: 12 months]
• Safety- Incidence of device and procedure related adverse events through 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form.
• Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
• Subjects between the ages of 22-65 years.
• History or failure with non-surgical weight-loss methods.
• 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.
• Have a Body Mass Index (BMI) of ≥ 30 and ≤ 50 kg/m².
• 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).
• Agrees to forego any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
• 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.
• 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.

Критерии исключения

• History of or intra-operative evidence of prior bariatric, gastric or esophageal surgery.
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.
• 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.
• Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
• Pancreatic insufficiency/disease.
• 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).
• Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in the next 12 months.
• History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.
• 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.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.
• Active gastric erosion, lesion, or gastric/duodenal ulcer.
• History of or current platelet or coagulation dysfunction, such as hemophilia.
• History or present use of insulin or insulin derivatives for treatment of diabetes.
• Patients with type II diabetes mellitus on oral agents (not injectables) with HgA1c > 9 at the time of enrollment.
• Active smoker or someone who has been a smoker in the 6 months leading up to the study.
• Portal hypertension and/or varices.
• Patient has a history of drug or alcohol abuse or positive at screening for drug use.
• Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
• 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.
• Beck Depression Inventory (Short) Score ≥ 12, and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
• Patient score >2 in any of the identified symptoms in the nausea/vomiting or bloating/distension domains on the Gastroparesis Cardinal Symptom Index (GCSI).
• Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
• Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
• Present or history of chronic abdominal pain.
• Participating in another clinical study that could compromise compliance with the POSE2.0 study (must be cleared with investigator and USGI Medical).
• Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06272201 · 50620 TPR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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