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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 21-65
- BMI ≥ 30 and ≤40 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required bythe procedure.
- History of failure with non-surgical weight-loss methods.
- Willingness to follow protocol requirements, including signed informed consent,routine follow-up schedule, completing laboratory tests, and completing dietcounseling.
- 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
- Ability to give informed consent.
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized)must agree to use adequate birth control methods.
- Reliable access to wi-fi and/or internet services.
Exclusion
Exclusion Criteria:
- History of foregut or gastrointestinal (GI) surgery (except uncomplicatedcholecystectomy or appendectomy).
- Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesiveperitonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach, or any type of hiatal herniasurgery.
- 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.
- 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.
- Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinalmetaplasia), history of familial and nan-familial adenomatous syndromes.
- A gastric mass or gastric polyps > 1 cm in size.
- A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm orsevere or intractable gastro-esophageal reflux symptoms.
- A structural abnormality in the esophagus or pharynx such as a stricture ordiverticulum that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Severe coagulopathy.
- 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.
- Subjects with any serious health condition unrelated to their weight that wouldincrease the risk of endoscopy.
- Chronic abdominal pain.
- Motility disorders of the GI tract such as gross esophageal motility disorders,gastroparesis or intractable constipation.
- Hepatic insufficiency or cirrhosis.
- Use of an intragastric device prior to this study due to the increased thickness ofthe stomach wall preventing effective suturing.
- Active psychological issues preventing participation in a life-style modificationprogram as determined by a psychologist.
- Patients unwilling to participate in an established medically supervised diet andbehavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with high dose aspirin (> 81mg daily),anti-inflammatory agents, anticoagulants, or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitormedication.
- Patients who are pregnant or breast-feeding.
- Patients currently taking weight-loss medications or other therapies for weight losswithin the prior 6 months.
- 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.
- Subjects taking medications on specified hourly intervals that may be affected bychanges to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
- Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
- Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary arterydisease.
- Pre-existing respiratory disease such as moderate or severe chronic obstructivepulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
- Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus,scleroderma) or immunocompromised.
- Specific diagnosed genetic disorder such as Prader Willi syndrome.
- Eating disorders including night eating syndrome (NES), bulimia, binge eatingdisorder, or compulsive overeating.
- Known history of endocrine disorders affecting weight such as uncontrolledhypothyroidism.
- At the discretion of the PI for subject safety
- 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
Connect with a study center
True You Weight Loss
Cary, North Carolina 27513
United StatesSite Not Available
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