ObesityNCT05578703
ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)
A study testing Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC and Apollo ESG in people with Obesity, run by True You Weight Loss at 1 site in United States.
Trial summary
The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC and Apollo ESG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
- History of at least one unsuccessful dietary effort to lose body weight
- Willing and able to participate in the study procedures
- Understand and voluntarily sign the informed consent
- Approved ESG candidate at TYWL
- Access to internet
- Reliable transportation to and from Cary, North Carolina surrounding area
Who cannot join
- Younger than 21 years of age
- Older than 65 years of age
- Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
- Milk and/or soy allergies
- History of any stomach manipulation (including repair of hiatal hernia)
- History of disordered eating
Show all 15Show fewer
- Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
- Hemoglobin A1c > 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis
- Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
- Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
- Patients who are pregnant or who plan to become pregnant during study duration
- Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
- Patients on chronic anticoagulation
- History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
- Concurrent use of weight loss medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss
The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG should be made available to patients as part of a comprehensive weight loss strategy.
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, 8 ostensibly due to fundic-sparing. In this study, the investigators propose to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation via standard nutrient drink test, and total body weight loss (TBWL), as well as the incidence of adverse events. Fundic ablation will be followed sequentially with ESG, to evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that, compared to baseline, FA-ESG will diminish fasting ghrelin levels, improve satiation, and induce a TBWL ≥ 15% at 12 months.
- Conditions
- Obesity
- Being tested
- Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC, Apollo ESG
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundic Ablation Sequentially in Combination with Endoscopic Sleeve GastroplastyProcedure or surgery
Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity
Fundic Mucosal Ablation with ERBE HybridAPCDevice
Fundic mucosal ablation utilizing approved ERBE HybridAPC
Apollo ESGDevice
Using only Apollo ESG as approved per label
| Study group | Role | What they receive |
|---|---|---|
| Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty | Experimental | Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty Receives: Procedure: Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty; Device: Fundic Mucosal Ablation with ERBE HybridAPC; Device: Apollo ESG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fasting Plasma Ghrelin Levels
Change from baseline for the quantitative determination of fasting ghrelin, total plasma measured by EIA/ELISA laboratory assays
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Timed Standardized Nutrient Drink Test
Measure timed consumption of a standardized nutrient drink test utilizing a sensation of satiation visual analogue scale. The severity of symptoms range from 0 (no symptoms) to 5 (maximum or unbearable fullness/satiation) and will measure volume to comfortable fullness (VTF) and maximum tolerated volume (MTV)
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)
Assess the severity of patient-reported gastroparesis symptoms. The GCSI gastroparesis symptoms score ranges from 0-none to 5-very severe. High scores reflect greater symptom severity
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS)
Rate the responses to the DAILY EATS questionnaire. The DAILY EATS questionnaire is designed to better understand patient's definitions, experience, and importance, of eating-related factors on a scale of 0-10. The DAILY EATS is a 5-item, patient-reported measure evaluating key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety)
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measure percent change in total body weight over time following FA alone and FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18
Change from Baseline in Weight Efficacy Life-Style Questionnaire Short Form (WEL-SF) composite score
Measure of eating self-efficacy consisting of 8-items on a scale of 0 (not at all confident) to 10 (very confident)
Measured: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Secondary outcomes (1)
Rate of safety and adverse events
FA and FA-ESG safety will be measured by the rate of serious adverse events (SAEs), adverse events (AEs), and accommodative symptom occurrence
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start9 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- True You Weight Loss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher E McGowan, MD, MSCR, Principal investigator, CEO/ Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578703
- Sponsor's protocol ID
- PS-001
- Status last verified
- May 2024
- First submitted
- 6 Oct 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 16105401Lopez-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 32193741Vijayvargiya P, Chedid V, Wang XJ, Atieh J, Maselli D, Burton DD, Clark MM, Acosta A, Camilleri M. Associations of gastric volumes, ingestive behavior, calorie and volume intake, and fullness in obesity. Am J Physiol Gastrointest Liver Physiol. 2020 Aug 1;319(2):G238-G244. doi: 10.1152/ajpgi.00140.2020. Epub 2020 Jul 6.
PubMed 32628074Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
PubMed 31788546Chial HJ, Camilleri C, Delgado-Aros S, Burton D, Thomforde G, Ferber I, Camilleri M. A nutrient drink test to assess maximum tolerated volume and postprandial symptoms: effects of gender, body mass index and age in health. Neurogastroenterol Motil. 2002 Jun;14(3):249-53. doi: 10.1046/j.1365-2982.2002.00326.x.
PubMed 12061909Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.
PubMed 35533995Fastenau J, Rozjabek H, Qin S, McLeod L, Nelson L, Ma J, Harris N. Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity. J Patient Rep Outcomes. 2020 Nov 23;4(1):99. doi: 10.1186/s41687-020-00259-w.
PubMed 33226548Ames GE, Heckman MG, Diehl NN, Grothe KB, Clark MM. Further statistical and clinical validity for the Weight Efficacy Lifestyle Questionnaire-Short Form. Eat Behav. 2015 Aug;18:115-9. doi: 10.1016/j.eatbeh.2015.05.003. Epub 2015 May 21.
PubMed 26042918
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss
- ClinicalTrials.gov ID
- NCT05578703
- Acronym / sponsor ID
- PS-001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- True You Weight LossUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Oct 2022 (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 research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG should be made available to patients as part of a comprehensive weight loss strategy.
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, 8 ostensibly due to fundic-sparing. In this study, the investigators propose to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation via standard nutrient drink test, and total body weight loss (TBWL), as well as the incidence of adverse events. Fundic ablation will be followed sequentially with ESG, to evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that, compared to baseline, FA-ESG will diminish fasting ghrelin levels, improve satiation, and induce a TBWL ≥ 15% at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty | Experimental | Procedure: Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Device: Fundic Mucosal Ablation with ERBE HybridAPC, Device: Apollo ESGSubjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
- History of at least one unsuccessful dietary effort to lose body weight
- Willing and able to participate in the study procedures
- Understand and voluntarily sign the informed consent
Key exclusion criteria (15 listed)
- Younger than 21 years of age
- Older than 65 years of age
- Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
- Milk and/or soy allergies
- History of any stomach manipulation (including repair of hiatal hernia)
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 |
|---|---|---|
| Fundic Ablation Sequentially in Combination with Endoscopic Sleeve GastroplastyFundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity | Procedure or surgery | Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty |
| Fundic Mucosal Ablation with ERBE HybridAPCFundic mucosal ablation utilizing approved ERBE HybridAPC | Device | Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty |
| Apollo ESGUsing only Apollo ESG as approved per label | Device | Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty |
Primary outcome
Change from Baseline in Fasting Plasma Ghrelin Levels
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Change from baseline for the quantitative determination of fasting ghrelin, total plasma measured by EIA/ELISA laboratory assays
Change from Baseline in Timed Standardized Nutrient Drink Test
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Measure timed consumption of a standardized nutrient drink test utilizing a sensation of satiation visual analogue scale. The severity of symptoms range from 0 (no symptoms) to 5 (maximum or unbearable fullness/satiation) and will measure volume to comfortable fullness (VTF) and maximum tolerated volume (MTV)
Change from Baseline in Gastroparesis Cardinal Symptom Index (GCSI)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Assess the severity of patient-reported gastroparesis symptoms. The GCSI gastroparesis symptoms score ranges from 0-none to 5-very severe. High scores reflect greater symptom severity
Change from Baseline in Daily Eats: Measuring Daily Eating Factors (DAILY EATS)
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Rate the responses to the DAILY EATS questionnaire. The DAILY EATS questionnaire is designed to better understand patient's definitions, experience, and importance, of eating-related factors on a scale of 0-10. The DAILY EATS is a 5-item, patient-reported measure evaluating key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety)
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18
Measure percent change in total body weight over time following FA alone and FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Change from Baseline in Weight Efficacy Life-Style Questionnaire Short Form (WEL-SF) composite score
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18
Measure of eating self-efficacy consisting of 8-items on a scale of 0 (not at all confident) to 10 (very confident)
1 secondary outcome
Rate of safety and adverse events
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, and Month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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 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 32628074Vijayvargiya P, Chedid V, Wang XJ, Atieh J, Maselli D, Burton DD, Clark MM, Acosta A, Camilleri M. Associations of gastric volumes, ingestive behavior, calorie and volume intake, and fullness in obesity. Am J Physiol Gastrointest Liver Physiol. 2020 Aug 1;319(2):G238-G244. doi: 10.1152/ajpgi.00140.2020. Epub 2020 Jul 6.
- Background: PubMed 31788546Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
- Background: PubMed 12061909Chial HJ, Camilleri C, Delgado-Aros S, Burton D, Thomforde G, Ferber I, Camilleri M. A nutrient drink test to assess maximum tolerated volume and postprandial symptoms: effects of gender, body mass index and age in health. Neurogastroenterol Motil. 2002 Jun;14(3):249-53. doi: 10.1046/j.1365-2982.2002.00326.x.
- Background: PubMed 35533995Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.
- Background: PubMed 33226548Fastenau J, Rozjabek H, Qin S, McLeod L, Nelson L, Ma J, Harris N. Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity. J Patient Rep Outcomes. 2020 Nov 23;4(1):99. doi: 10.1186/s41687-020-00259-w.
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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. This study is not recruiting at the moment.
Christopher E McGowan, MD, MSCR principal investigator
CEO/ Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC and Apollo ESG in people with 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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Fasting Plasma Ghrelin Levels (time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, and Month 18). The study lists 6 primary outcomes in all. 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 NCT05578703, which also lists 13 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 14 May 2024.