NCT06420700Recruiting
Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
Source: ClinicalTrials.gov · Last updated 22 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 14 May 2024
- Start date
- 31 Jan 2024
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- True You Weight Loss
- Diseases
- Obesity
- NCT number
- NCT06420700
What you commit to
- Study type: Observational
- Planned participants: 100
- From 31 Jan 2024 to the primary completion date, 31 Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
Other illness
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
Other
- Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
- Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
- Patients who are pregnant or breast-feeding.
- At the discretion of the PI for subject safety
Who the study is looking for
- Age ≥ 18 years and ≤ 65 years old
- BMI ≥ 28 and ≤55 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- 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.
- Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| True You Weight Loss Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| True You Weight Loss Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.