Ensayos clínicos

The purpose of this study is to determine the prevalence of esophageal dysmotility among patients following bariatric surgery.

The purpose of this study is to assess the feasibility of ablation of up to 70% of the gastric mucosa using HybridAPC to induce weight loss.  

The purpose of this study is to learn about the ways which people who have had bariatric surgery and lose weight very quickly must cope with many social and personal changes, and the ways they felt prepared or not for these changes.

Though nicotine is known to be a mild analgesic, its use in the peri-operative period to reduce postoperative opioid requirements has only recently been investigated. In nonsmokers it has been shown to reduce postoperative pain and opioid requirements in both female patients undergoing uterine surgery and male patients undergoing prostatectomy. We have recently confirmed these findings in women undergoing uterine surgery by open, laparoscopic and vaginal approaches. In this study we found a 30% mean reduction of 24 hour postoperative opioid requirements following the administration of a 3 mg dose of nicotine nasal spray. Two previous studies with perioperative transdermal ...

The purpose of this study is to evaluate a treatment for obesity.

The purpose of this study is to determine the effects of blocking the receptors of the Glucagon-like Peptide-1 (GLP-1) hormone after different types of bariatric surgery on the regulation of food intake and appetite control.

The purpose of the research study is to find out whether patients with low ferritin levels following bariatric surgery develop bothersome restless leg symptoms.

The purpose of this study is to examine the effect of Ghrelin on the regulation of food intake and sensation of fullness after bariatric surgery.

The purpose of this study is to assess the associated effects of probiotic supplements on weight loss, visceral and total body fat, and changes in the biological environment of the digestive tract in patients who have had bariatric surgery.

The purpose of this study is to measure the safety and effectiveness of the Maestro System to reduce body weight by blocking signals from the vagus nerve in people who are considered to be obese.

The purpose of this study is is to assess the feasibility and acceptability of telehealth for increasing access to bariatric surgery and compare outcomes to patients who receive F2F visits.

The purpose of this study is to determine the prevalence of esophageal dysmotility among patients following bariatric surgery.
 

The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

Using stem cell derived intestinal epithelial cultures (enteroids) derived from obese (BMI> 30) patients and non-obese and metabolically normal patients (either post-bariatric surgery (BS) or BS-naïve with BMI < 25), dietary glucose absorption was measured. We identified that enteroids from obese patients were characterized by glucose hyper-absorption (~ 5 fold) compared to non-obese patients. Significant upregulation of major intestinal sugar transporters, including SGLT1, GLU2 and GLUT5 was responsible for hyper-absorptive phenotype and their pharmacologic inhibition significantly decreased glucose absorption. Importantly, we observed that enteroids from post-BS non-obese patients exhibited low dietary glucose absorption, indicating that altered glucose absorption ...

The purpose of this study is to evaluate the safety and effectiveness of the Spatz3 in subjects with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program.

The purpose of this study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling.

Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks.

Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects ...

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

The purpose of this study is to improve our understanding of why gastrointestinal symptoms occur in diabetes mellitus patients and identify new treatment(s) in the future.  

These symptoms are often distressing and may impair glycemic control. We do not understand how diabetes mellitus affects the GI tracy. In 45 patients undergoing sleeve gastrectomy, we plan to compare the cellular composition of circulating peripheral mononuclear cells, stomach immune cells, and interstitial cells of Cajal in the stomach. 

This study aims to assess adipose tissue-eosinophil content and adiopose tissue metabolism 3 months after endoscopic gastroplasty weight loss procedure.

The purpose of this study is to collect and maintain a clinical and pathology database, and a biobank of blood, stool, and tissue specimens, from patients being treated surgically for obesity. The hope is this will ultimately help identify biological predictors for matching the best bariatric surgery to the patient for maximizing the effectiveness of the weight loss.

The purpose of this study is to determine plasma levels of Peptide YY  (PYY), ghrelin, ammonia, and amino acids prior to and after Roux-en-Y gastric bypass surgery.

The purpose of this study is to identify changes to the metabolome (range of chemicals produced in the body) and microbiome (intestine microbe environment) that are unique to Roux-en-Y gastric bypass surgery and assess the associated effect on the metabolism of patients with type 2 diabetes.

This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.

The purpose of this study is to understand outcomes from patients who have undergone roux-en-y gastric bypass and developed postprandial hypoglycemia which required surgery.   

The purpose of this study is to assess the acceptability and accuracy of the smart phone food record App ‘HealthWatch 360’ in collecting food intake data from subjects. The nutritional analysis obtained will be compared with that of a 24 hour recall to assess accuracy.

The purpose of this study is to assess the effectiveness, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subject's last dose of study ...

It is unknown whether the bile acid pathway reacts differently to weight loss resulting from Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction alone.

The purpose of this study is to determine the effect of endogenous glucagon-like peptide-1 on active intestinal glucose transport and on intestinal permeability.

The purpose of this study is to learn more about the effects of similar weight loss through caloric restriction, gastric reduction, and bypass of the proximal small intestines on gut microbiota and compare them to changes in the microbiome of obese subjects undergoing sham procedures and life-style modification.

This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a ...

The purpose of this study is to determine the isotopic composition of the transition metals Cu, Fe and Zn after bariatric surgery.

The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.

Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea. Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. This study is being done to find out ...

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We are completing ...

The purpose of this study is to assess the impact of participation in a standardized behavioral weight management program on the percentage of excess weight lost and also the psychosocial and medical outcomes after  gastric bypass surgery.

The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves ...

This study aims to evaluate the mechanisms leading to hyperoxaluria and increased risk of kidney stone formation after bariatric surgery.

The purpose of this study is to assess if a larger interventional study is possible.  This study will follow subjects wearing a small device  that sticks to the skin temporarily to collect vitals information. This information is routed by 4G/5G wireless technology to a secured data system on the internet accessable by study team and funding sponsor personnel without any personally identifiable information for the assessment of connectivity, accuracy, and usefullness as compared to current health monitoring systems in clinical use both on-site at the hospital and at home. 

The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an Endoscopic Gastric Remodeling Weight Loss procedure (EGRWL).  

The primary aim is to study the correlation between changes in the gut microbiome of obese subjects undergoing an intragastric balloon procedure.

The purpose of this study is to compare weight loss, improvement of comorbidities, improvement of lipid profile, blood sugar in patients undergoing endoscopic sleeve gastroplasty or intragastric balloon between patients who are in a weight loss program and those who are not.

The objectives of this study are to identify circulating extracellular vesicle (EV)-derived protein and RNA signatures associated with Type 2 Diabetes (T2D), and to identify changes in circulating EV cargo in patients whose T2D resolves after sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB).

The purpose of this study is to establish a new protocol and normative values for evaluating gastric emptying and accommodation in bariatric surgery patients.

The objectives of this study are to assess the safety and durability of combined hybrid APC and ESG compared to traditional ESG, and to assess weight loss and improvement in obesity-related co-morbidities in combined hybrid APC and ESG compared to ESG alone.

The purpose of this study is to explore the effectiveness and safety of a modified gastroplication technique for weight loss in five patients with obesity, and includes physiologic appraisal of gastric emptying (via gastric emptying breath test) and post-prandial gastric accommodation (via SPECT).

The purpose of this study is to investigate the change in quality of life after endoscopic bariatric therapies and to correlate the changes in quality of life with changes in weight after endoscopic bariatric Therapies (EBTs).

The primary purpose of this study is to determine bariatric patients’ preference of telemedicine or in-person assessment for post-operative care.

The purpose of this study is to prospectively evaluate the safety and effectiveness of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing liver transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

The aims of this study are to compare the diagnostic accuracy of FEHI, a non-invasive, non-drug, spectral imaging technology to current standard of care, ICG fluorescein imaging, with regard to intraoperative tissue ischemia, to estimate the optimal threshold value for SpO2 in FEHI to achieve optimal correlation with ICG imaging, and to compare the time needed to complete FEHI compared to ICG. These will be compared in the final 70% of cases to avoid learning curve bias on the first cases.

The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.

The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.