ObesityNCT06428617
Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)
An observational study of Obesity, run by True You Weight Loss at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Jun 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo Gastric Fundus Mucosal Ablation (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. All eligibility criteria must be met at the time of enrollment.
Who may be able to join
- Age ≥ 18 years and ≤ 65 years old
- BMI ≥ 27 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 fundus mucosal ablation procedure at True You Weight Loss regardless of the research
Who cannot join
- 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.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- Patients with previous or current tobacco use
- Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
Show all 9Show fewer
- Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
- Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
- At the discretion of the PI for subject safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
True You Weight Loss
Cary, North Carolina, 27513
Chase Wooley, BS, 919-336-4171, Chase@trueyouweightloss.com
Shannon Casey, BS, MS, (919) 391-7843, Shannon@trueyouweightloss.com
About this study
Official title: A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- obesity, ghrelin, hunger, ablation, True You Weight Loss, hunger hormone, fundus, fundus ablation, fundic ablation, GFMA
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) * 100 measured as a percentage.
Measured: 12 Months
Secondary outcomes (3)
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) * 100 measured as a percentage.
Measured: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Percent Excess Weight Loss from Baseline (EWL)
Measured excess weight loss percentage from baseline following Gastric Fundic Mucosal Ablation. %EWL = (pre-op weight - post op body weight) / (pre-op weight - ideal body weight) * 100
Ideal Body Weight (IBW):
Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet
Measured: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Change in Body Mass Index (BMI) from Baseline
Measured Body Mass Index (BMI) from baseline following Gastric Fundic Mucosal Ablation. Body Mass Index (BMI) = (Weight in kilograms) / ((Height in meters)^2)
Measured: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jun 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- True You Weight Loss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428617
- Sponsor's protocol ID
- RGT-002
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
- ClinicalTrials.gov ID
- NCT06428617
- Acronym / sponsor ID
- RGT-002
- Conditions
- Obesity
- Keywords
- obesity, ghrelin, hunger, ablation, True You Weight Loss, hunger hormone, fundus, fundus ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- True You Weight LossUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo Gastric Fundus Mucosal Ablation (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. All eligibility criteria must be met at the time of enrollment.
Key inclusion criteria (6 listed)
- Age ≥ 18 years and ≤ 65 years old
- BMI ≥ 27 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.
Key exclusion criteria (9 listed)
- 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.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- Patients with previous or current tobacco use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame: 12 Months
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) * 100 measured as a percentage.
3 secondary outcomes
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Percent Excess Weight Loss from Baseline (EWL)
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Change in Body Mass Index (BMI) from Baseline
Time frame: 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by True You Weight Loss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chase Wooley, BS (919-336-4171, Chase@trueyouweightloss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Total Body Weight Loss (TBWL) from Baseline (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.