ObesityNCT06420700
Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
An observational study of Obesity, run by True You Weight Loss at 2 sites 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 combined gastric mucosal ablation with endoscopic sleeve gastroplasty 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
- What is being tested?
- Combined gastric mucosal ablation with endoscopic sleeve gastroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2024to 31 Jan 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: Patients (Age ≥ 18 years and ≤ 65 and BMI ≥ 28 and ≤55 kg/m²) who underwent combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss locations (Cary, NC and Atlanta, GA) regardless of their voluntary participation in the research
Who may be able to join
- 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
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.
- Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- At the discretion of the PI for subject safety
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
True You Weight Loss
Atlanta, Georgia, 30342
Chase Wooley, BS, 919-336-4171, Chase@trueyouweightloss.com
Shannon Casey, BS, MS, (919) 391-7843, Shannon@trueyouweightloss.com
- 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 Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty 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 combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.
Read the detailed description
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. While the ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus. The proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic hormone, which has been linked to increased calorie intake and weight gain. Studies have observed reduced levels of ghrelin along multiple timepoints following LSG and this has been attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting ghrelin levels, ostensibly due to fundic-sparing. In a preliminary, first-in-human study conducted by True You Weight Loss (ABLATE Weight), gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months. In this 10-patient study, fundus ablation was performed safely in all cases and without serious adverse events. A subsequent first-in-human study (ABLATE WEIGHT 2) further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session. Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile. By constructing a multi-site, prospective registry, the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty (ESG) at True You Weight Loss.
- Conditions
- Obesity
- Being tested
- Combined gastric mucosal ablation with endoscopic sleeve gastroplasty
- Keywords
- ghrelin, fundus ablation, gastric mucosal ablation, endoscopic sleeve gastroplasty, ESG-MAX, obesity, ablation, hunger, True You Weight Loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined gastric mucosal ablation with endoscopic sleeve gastroplastyProcedure or surgery
Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity
| Study group | Role | What they receive |
|---|---|---|
| Combined gastric mucosal ablation with endoscopic sleeve gastroplasty | All patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study. Receives: Procedure: Combined gastric mucosal ablation with endoscopic sleeve gastroplasty |
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 combined Gastric 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 combined Gastric 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 combined Gastric 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 combined Gastric 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 posted20 May 2024
- Study start31 Jan 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 100 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
- NCT06420700
- Sponsor's protocol ID
- RGT-001
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.
PubMed 3915747Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.
PubMed 17200702Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9.
PubMed 22231739Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.
PubMed 23794092McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
PubMed 31592891Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.
PubMed 16105401Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3.
PubMed 19638921Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0.
PubMed 32193741Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
- ClinicalTrials.gov ID
- NCT06420700
- Acronym / sponsor ID
- RGT-001
- Conditions
- Obesity
- Keywords
- ghrelin, fundus ablation, gastric mucosal ablation, endoscopic sleeve gastroplasty, ESG-MAX, obesity, ablation, hunger
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- True You Weight LossUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 20 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 combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.
Detailed description
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. While the ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus. The proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic hormone, which has been linked to increased calorie intake and weight gain. Studies have observed reduced levels of ghrelin along multiple timepoints following LSG and this has been attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting ghrelin levels, ostensibly due to fundic-sparing. In a preliminary, first-in-human study conducted by True You Weight Loss (ABLATE Weight), gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months. In this 10-patient study, fundus ablation was performed safely in all cases and without serious adverse events. A subsequent first-in-human study (ABLATE WEIGHT 2) further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session. Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile. By constructing a multi-site, prospective registry, the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty (ESG) at True You Weight Loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined gastric mucosal ablation with endoscopic sleeve gastroplasty | – | Procedure: Combined gastric mucosal ablation with endoscopic sleeve gastroplastyAll patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (Age ≥ 18 years and ≤ 65 and BMI ≥ 28 and ≤55 kg/m²) who underwent combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss locations (Cary, NC and Atlanta, GA) regardless of their voluntary participation in the research
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 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.
- Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined gastric mucosal ablation with endoscopic sleeve gastroplastyCombined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity | Procedure or surgery | Combined gastric mucosal ablation with endoscopic sleeve gastroplasty |
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 combined Gastric 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 22 May 2024.
- Background: PubMed 3915747Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.
- Background: PubMed 17200702Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.
- Background: PubMed 22231739Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9.
- Background: PubMed 23794092Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.
- Background: PubMed 31592891McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
- Background: PubMed 16105401Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.
- Background: PubMed 19638921Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3.
- Background: PubMed 32193741Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
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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.
2 sites 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 2 sites 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 6 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
On the ClinicalTrials.gov record for NCT06420700, which also lists 9 linked publications.
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 22 May 2024.