Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428617
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
Fundus Ablation Registry Gastric Fundus Mucosal Ablation for Weight Loss
Sponsor:
True You Weight Loss
Organization:
True You Weight Loss
Study Overview
Official Title:
A Multi-site Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to construct a multi-site prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss
Detailed Description:
Obesity is a chronic progressive multifactorial disease that contributes to increasing morbidity mortality and economic costs worldwide The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides leading to calorie-ingesting behaviors and weight gain A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity This is a multi-site prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation GFMA at a True You Weight Loss site in Cary NC or Atlanta GA Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site Cary NC or Atlanta GA prior to their involvement in the study Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator Study participants will receive follow-up care according to standard of care practices regardless of their involvement in the research study Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring Patient weights and adverse events will be collected at each visit Adverse events will be communicated to medical team members in between dedicated visits We aim to establish a multi-site prospective registry to longitudinally describe GMFA in adults with obesity including patient characteristics weight loss improvement in weight-related medical conditions and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None