(Validation study led by True You Weight Loss)
True You is excited to launch the new Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET) 2.0: A Single-Center Randomized Controlled Validation Trial in a Community Setting. This investigational research study will be led by our True You Research Team. Are you interested in receiving an ESG at True You and contributing to evidence-based research? If so, please see below and get to know the study.
- What: True You Weight Loss is seeking people approved to have an Endoscopic Sleeve Gastroplasty (ESG) with a body mass index (BMI) at and between 30 – 40 to participate in a research study in order to observe potential improvements to the established ESG procedure. This is a weight loss procedure performed to reduce the size of your stomach. The ESG is a weight loss procedure that reduces the size of the stomach to help you feel fuller, eat smaller portions, and lose weight. In combination with Hybrid Argon Plasma Coagulation (HAPC) technique to aid in tissue repair, it is thought that a hybrid ESG with APC may aid in durability of sutures and lead to improved weight loss outcomes. At this time, more evidence is needed to confirm that adding APC improves both the safety and durability of the ESG procedure and our patients can help!
- When: From the time of study enrollment, your participation would last up to 16 months. This includes 3-4 months for screening assessments and 12 months for active study participation activities.
- Where: We are now actively recruiting patients. Patients must receive the ESG and follow up procedures at the Cary, NC, True You Weight Loss location.
- Why: To investigate a new technique to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone.
- How: Contact us today if you are interested in participating.
- Compensation: Participants will be responsible for the cost of the ESG procedure, but will be compensated for their study-related time, effort and inconvenience with non-monetary as well as monetary means.
- Who: Patients approved for an ESG procedure with True You. You may be eligible to participate if you fit the following inclusion criteria:
- Age 21-65
- BMI ≥ 30 and ≤40 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the 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 diet counseling.
- 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.
- Residing within a reasonable distance from the investigator’s office (Cary, NC) and able to travel to the investigator to complete all routine follow-up visits as applicable.
- Reliable access to wi-fi and/or internet services.
- Approved to undergo the ESG procedure at True You Weight Loss following a consultation with our medical team.
Additional information about the study can be accessed via ClinicalTrials.gov. You may also download a flyer with the details.
