ObesityFULNESSNCT06438510
The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)
A study testing Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) in people with Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2023to 1 Jun 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9).
- Age between 18 and 65 years (both inclusive).
- Treatment naïve for bariatric surgery or endoscopic bariatric therapy.
- Patients that have been evaluated by the local MDT and have indication to ESG.
- Willingness to comply with the substantial behavioral modifications program as required by the procedure.
- Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
- Women of childbearing potential should have negative urine beta human chorionic gonadotropin (hCG) pregnancy test and must agree to use acceptable contraception methods throughout the study duration.
- Able to comply with study requirements and understand and sign the Informed Consent Form.
Who cannot join
- Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), or other endoscopic bariatric procedures or conditions,
- Prior intra-gastric balloon or another gastric implant.
- History of a structural or functional disorder of the esophagus or pharynx that may impede passage of the device such as achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolled GERD defined as LA grade C esophagitis or greater.
- History of a structural or functional disorder of the stomach including gastric polyps > 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronic gastritis, gastric varices, hiatal hernia (>4 cm) of axial displacement of the z-line above the diaphragm.
- Active H. pylori infection (subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
- Patients with history of intestinal stricture/stenosis, small bowel or colonic obstruction or any other obstructive disorder of the GI tract such as adhesive peritonitis and/or abdominal adhesions.
Show all 26Show fewer
- Patients with any inflammatory disease (IBD).
- Autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
- Active hepatitis, active liver disease, hepatic insufficiency , or cirrhosis.
- Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening.
- Patients with PCOS (hormonal dis-balances).
- Persistent Anemia, defined as Hemoglobin <10 g/dL.
- Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months.
- Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).
- Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
- HbA1c > 8.5 %.
- Patients requiring exogenous insulin.
- Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors.
- Coagulopathy, congenital or acquired intestinal telangiectasia.
- Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
- Pregnant or breast-feeding woman.
- Patients with history or current abuse of drugs or alcohol.
- Patients who are taking medications that cause weight loss such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
- Patients who are taking medication that cause weight gain such as anti-depressants
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Ivo Boskoski, +390630156580, ivo.boskoski@policlinicogemelli.it
About this study
Official title: A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity
Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Read the detailed description
Obesity is one of the most prevalent diseases worldwide with a major impact on the health care system in many countries. Bariatric surgery is currently the first treatment option in obese patients because it offers lasting results on body weight loss and reduces disease-related comorbidities. In recent years, however, endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective method in treating obese patients. Considering the lower complication rate compared with bariatric surgery and the greater weight loss compared with medical therapy, ESG finds indication as a treatment in cases of class I and II obesity. In cases of BMI > 40 or higher, bariatric surgery is actually the best option to achieve lasting weight loss but may be burdened by significant morbidity and mortality related to the surgery itself. Ghrelin is a potent oressigenic hormone produced and secreted mainly by the endocrine cells of the gastric glands at the bottom of the stomach and acts in the brain to regulate food intake. Gastric ghrelin plays a key role in glucose metabolism. Obese patients generally show reduced levels of ghrelin and a high percentage of these patients are insulin-resistant, have high circulating levels of insulin, hyperglycemia or diabetes. Through gene expression data and electron microscopy the activity of GPCs (ghrelin-like cells) could be increased in obese patients and correlates with glycemic levels. A positive correlation has been suggested between ghrelin gene expression, glycemic values and body mass index in obese patients. Taken together, these data indicate that ghrelin overproduction by the stomach may be involved in the weight gain and pathogenesis of type 2 diabetes in obese patients. This study aims to demonstrate how further ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Indeed, HybridAPC could stimulate fundus stem cells to produce new ghrelin-secreting endocrine cells with normal secretory activity as in lean subjects. Thus normalizing ghrelin signaling to appetite/hunger areas in the brain relayed through the gut brain axis. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
- Conditions
- Obesity
- Being tested
- Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)Procedure or surgery
All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | All patients undergo Endoscopic Sleeve Gastroplasty (ESG) and HybridAPC. ESG will be performed using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a gastroscope. Full- thickness sutures will be placed from the angulus to the gastric fundus using a U-shaped pattern with 2.0 nonabsorbable suture thread. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. HybridAPC is an highly controlled mucosal lift applied by the waterjet function and the subsequent thermal ablation applied by APC. First the fluid cushion is injected into submucosa until a size in the range of 2 - 3 cm is achieved (pressure setting of E20 up to E 30). Second the mucosa is being ablated on the surface of this fluid cushion (30 - 50 Watts, argon gas flow 0.8 L/min) Receives: Procedure: Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Safety, Tolerability and Efficacy of HybridAPC for gastric mucosa ablation of the fundus in patients undergoing endoscopic sleeve gastroplasty
Measured: 18 months
HybridAPC
To assess the additional effect of gastric mucosa ablation in the fundus by HybridAPC upon ESG on total body weight (Kilograms) over time
Measured: 18 months
Secondary outcomes (3)
Gastric Hormones
assess changes in plasma levels of gastric hormones. Fasting blood samples will be taken at baseline and 1, 6 and 12 months follow up visits and stored at -80℃ until assayed. Hormone measurement will be conducted using enzyme-linked immunosorbent assay (ELISA). Assay validation is performed by the manufacturer, testing the precision of the assay and its sensitivity.
Ghrelin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity < 0.094 ng/ml and an intra- and inter-assay precision <10% and <10%, respectively.
Leptin levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity < 10 pg/ml and an intra- and inter-assay precision <6.4% and <7.4%, respectively.
GLP-1 levels will be measured by ELISA (Lifespan Biosciences, Seattle, WA) with a sensitivity < 0.31 ng/ml and an intra- and inter-assay precision <9.09% and <8.33%, respectively.
Measured: 18 months
Life changes
assess quality of life changes at baseline and 1,6,12 months follow up using the BAROS, SF-36 and IWQOL-Lite-CT questionnaire.
Measured: 18 months
Comorbidity
Comorbidity improvements after ESG and Hybrid APC: Hypertension improvement was considered upon reaching values of PA < 130/80 mmHg or if antihypertensive therapy was discontinued while maintaining pressure values <130/80 mmHg. Hyperinsulinemia improvement was considered if the achieved HOMA score was < 1.8 at any time during follow-up after ESG. Type 2 diabetes mellitus (DMT2) improvement will be considered if the achieved fasting blood glucose will be on values < 126 mg/dl in at least 2 different measurements or if the glycated hemoglobin value will be < 6 % or if medical therapy will discontinue. Obstructive sleep apnea syndrome (OSAS) improvement will be considered if nocturnal pO2 > 92% or if symptoms will disappear without the use of CPAP.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start8 Oct 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOSKOSKI IVO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- ivo boskoski, Principal investigator, Fondazione Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438510
- Sponsor's protocol ID
- 5646
- Acronym
- FULNESS
- Status last verified
- May 2024
- First submitted
- 15 Jun 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity
- ClinicalTrials.gov ID
- NCT06438510
- Acronym / sponsor ID
- FULNESS / 5646
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 3 Jun 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.
Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Detailed description
Obesity is one of the most prevalent diseases worldwide with a major impact on the health care system in many countries. Bariatric surgery is currently the first treatment option in obese patients because it offers lasting results on body weight loss and reduces disease-related comorbidities. In recent years, however, endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective method in treating obese patients. Considering the lower complication rate compared with bariatric surgery and the greater weight loss compared with medical therapy, ESG finds indication as a treatment in cases of class I and II obesity. In cases of BMI > 40 or higher, bariatric surgery is actually the best option to achieve lasting weight loss but may be burdened by significant morbidity and mortality related to the surgery itself. Ghrelin is a potent oressigenic hormone produced and secreted mainly by the endocrine cells of the gastric glands at the bottom of the stomach and acts in the brain to regulate food intake. Gastric ghrelin plays a key role in glucose metabolism. Obese patients generally show reduced levels of ghrelin and a high percentage of these patients are insulin-resistant, have high circulating levels of insulin, hyperglycemia or diabetes. Through gene expression data and electron microscopy the activity of GPCs (ghrelin-like cells) could be increased in obese patients and correlates with glycemic levels. A positive correlation has been suggested between ghrelin gene expression, glycemic values and body mass index in obese patients. Taken together, these data indicate that ghrelin overproduction by the stomach may be involved in the weight gain and pathogenesis of type 2 diabetes in obese patients. This study aims to demonstrate how further ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. Indeed, HybridAPC could stimulate fundus stem cells to produce new ghrelin-secreting endocrine cells with normal secretory activity as in lean subjects. Thus normalizing ghrelin signaling to appetite/hunger areas in the brain relayed through the gut brain axis. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)All patients undergo Endoscopic Sleeve Gastroplasty (ESG) and HybridAPC. ESG will be performed using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a gastroscope. Full- thickness sutures will be placed from the angulus to the gastric fundus using a U-shaped pattern with 2.0 nonabsorbable suture thread. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. HybridAPC is an highly controlled mucosal lift applied by the waterjet function and the subsequent thermal ablation applied by APC. First the fluid cushion is injected into submucosa until a size in the range of 2 - 3 cm is achieved (pressure setting of E20 up to E 30). Second the mucosa is being ablated on the surface of this fluid cushion (30 - 50 Watts, argon gas flow 0.8 L/min) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9).
- Age between 18 and 65 years (both inclusive).
- Treatment naïve for bariatric surgery or endoscopic bariatric therapy.
- Patients that have been evaluated by the local MDT and have indication to ESG.
- Willingness to comply with the substantial behavioral modifications program as required by the procedure.
Key exclusion criteria (26 listed)
- Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), or other endoscopic bariatric procedures or conditions,
- Prior intra-gastric balloon or another gastric implant.
- History of a structural or functional disorder of the esophagus or pharynx that may impede passage of the device such as achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolled GERD defined as LA grade C esophagitis or greater.
- History of a structural or functional disorder of the stomach including gastric polyps > 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronic gastritis, gastric varices, hiatal hernia (>4 cm) of axial displacement of the z-line above the diaphragm.
- Active H. pylori infection (subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
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 |
|---|---|---|
| Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied. | Procedure or surgery | Single arm |
Primary outcome
Incidence of Adverse Events
Time frame: 18 months
Safety, Tolerability and Efficacy of HybridAPC for gastric mucosa ablation of the fundus in patients undergoing endoscopic sleeve gastroplasty
HybridAPC
Time frame: 18 months
To assess the additional effect of gastric mucosa ablation in the fundus by HybridAPC upon ESG on total body weight (Kilograms) over time
3 secondary outcomes
Gastric Hormones
Time frame: 18 months
Life changes
Time frame: 18 months
Comorbidity
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
ivo boskoski principal investigator
Fondazione Policlinico Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) in people with Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 26 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 3 Jun 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 Italy. 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?
Contact Ivo Boskoski (+390630156580, ivo.boskoski@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 18 months). The study lists 2 primary outcomes in all. 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 3 Jun 2024.