Is NCT06671119 recruiting in Cary, NC?

Yes, NCT06671119 is currently recruiting participants at its Cary, NC location. This obesity and obesity-related medical conditions clinical trial is actively enrolling qualified participants.

Is participation in this Cary clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obesity and Obesity-related Medical Conditions Clinical Trial in Cary, NC

Q: How do I join the obesity and obesity-related medical conditions clinical trial in Cary?

To join this clinical trial in Cary, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Obesity and Obesity-related Medical Conditions Study in Cary

The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Sponsor: Dr. Christopher McGowan

Who Can Participate

Inclusion Criteria

Male and female patients who have:

BMI of 30 kg/m2 or greater, AND

regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%

Must have undergone SG at least three years before the time of enrollment

Age range: 22 - 60 years

Must agree to refrain from using weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dual GLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counter weight loss medications or supplements throughout the study.

Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.

Must agree not to donate blood during participation in the study.

Should be able to comply with study requirements, understand, and sign the Informed Consent Form.

Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.

Should have a history of failure to lose weight using conventional diet and lifestyle therapies.

Must have reliable access to wifi and/or internet services.

Must express willingness to comply with the substantial lifelong dietary restrictions required by the procedure.

Exclusion Criteria

Inadequate response to sleeve gastrectomy

Patients requiring exogenous insulin.

HbA1c \> 8.5%

Pregnant or breast-feeding or intending to get pregnant during the study.

Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.

History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).

Change in diabetic treatment within the last three months.

Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium-dependent glucose co-transporter 2 (SGLT-2) inhibitors.

GLP-1 use in the preceding 6 months.

Known autoimmune disease, other than autoimmune thyroid disease, which is adequately replaced, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.

Previous endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.

History of diabetic gastroparesis.

Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis.

Acute gastrointestinal illness in the previous 7 days.

Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn's disease.

Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase the risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus.

Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug-refractory esophageal reflux symptoms.

Known history of a structural or functional disorder of the stomach, including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\>3 cm), cancer, or any other disorder of the stomach.

Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia, or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting, or early satiety.

Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea, or vomiting.

Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).

History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.

Current use of anticoagulation therapy.

Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure.

Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.

Use of drugs known to affect GI motility (e.g., Metoclopramide).

Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine, GLP-1 agonists, GIP/GLP-1 dual agonists, or over-the-counter weight loss medications at screening.

Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on a stable dose for at least 6 weeks prior to Screening.

Persistent Anemia, defined as Hemoglobin \<10 g/dL.

Significant cardiovascular disease including a known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within the last 6 months.

Known moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 (estimated by MDRD).

Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.

Active systemic infection.

Known active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).

Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.

Not a candidate for surgery or general anesthesia.

Active illicit substance abuse or alcoholism.

Current smoker or smoking history in the last six months.

Participating in another ongoing clinical trial of an investigational drug or device.

Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.

Other medical conditions that do not allow for an endoscopic procedure.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cary?

Yes, this clinical trial (NCT06671119) has an active research site in Cary, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity and Obesity-related Medical Conditions Treatment Options in Cary, NC

If you're searching for obesity and obesity-related medical conditions treatment options in Cary, NC, this clinical trial (NCT06671119) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cary research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity and obesity-related medical conditions specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity and obesity-related medical conditions clinical trials near you to find additional studies recruiting in your area.

Obesity and Obesity-related Medical Conditions Clinical Trial in Cary, NC

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