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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05587491




Registration number
NCT05587491
Ethics application status
Date submitted
17/10/2022
Date registered
20/10/2022
Date last updated
4/06/2024

Titles & IDs
Public title
HybridAPC for Gastric Mucosal Ablation in Obese Patients.
Scientific title
Feasibility and Safety of HybridAPC for Gastric Mucosal Ablation in the Management of Patients With Obesity.
Secondary ID [1] 0 0
2021_03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Adiposity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hybrid Argonplasma coagulation (HAPC)

Other: Gastric mucosal ablation - Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid argonplasma.


Treatment: Devices: Hybrid Argonplasma coagulation (HAPC)
Gastric mucosal ablation is an endoscopic procedure which uses argonplasma coagulation in combination with submucosal injection to achieve selective ablation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of the % of total body weight loss (% TBWL).
Timepoint [1] 0 0
9 months

Eligibility
Key inclusion criteria
1. Male or females patients in the range of class I to class III obesity (30 = BMI = 45).
2. Age 21 - 75 yrs.
3. Treatment naïve for bariatric surgery or endoscopic bariatric therapy
4. 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.
5. Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
6. Agree not to donate blood during their participation in the study.
7. Able to comply with study requirements and understand and sign the Informed Consent Form.
8. Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to screening visit.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients requiring exogenous insulin.
2. HbA1c > 9.5 %
3. Pregnant or breast-feeding or intending to get pregnant during the study.
4. Unwilling or unable to complete the patient diary, or comply with study visits and other study procedures as required per protocol.
5. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
6. Probable insulin production failure, defined as fasting C-Peptide serum < 1 ng/mL (333 pmol/l).
7. Previous use of any types of insulin for > 1 month (at any time, except for treatment of gestational diabetes).
8. Change in diabetic treatment within the last three months.
9. 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.
10. Change of diabetes medication or doses 12 weeks prior to screening visit.
11. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year).
12. Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
13. Previous upper GI surgery, or other endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
14. History of diabetic gastroparesis.
15. Known active hepatitis or active liver disease.
16. Acute gastrointestinal illness in the previous 7 days.
17. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
18. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus.
19. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
20. Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3 cm), cancer or any other disorder of the stomach.
21. Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety.
22. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting.
23. 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).
24. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
25. Current use of anticoagulation therapy
26. Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure
27. 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.
28. Use of drugs known to affect GI motility (e.g. Metoclopramide).
29. Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine or over the counter weight loss medications at screening.
30. 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.
31. Persistent Anemia, defined as Hemoglobin <10 g/dL.
32. Subjects who have donated blood or received a transfusion in the prior 3 months.
33. Subjects with conditions that alter red blood cell turnover.
34. Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months.
35. Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).
36. 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.
37. Active systemic infection.
38. Active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
39. Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
40. Not a candidate for surgery or general anesthesia.
41. Active illicit substance abuse or alcoholism.
42. Current smoker or smoking history in the last six months.
43. Participating in another ongoing clinical trial of an investigational drug or device.
44. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
45. Other medical condition that does not allow for endoscopic procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Bariatric & Metabolic Institute The BMI Clinic - Double Bay
Recruitment postcode(s) [1] 0 0
2028 - Double Bay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Erbe Elektromedizin GmbH
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ERBE AUSTRALIA PTY LTD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure.

Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obese participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC.

As primary endpoint the % total body weight loss (TBWL) will be determined as body weight difference at the final 6 months FU after the last treatment session in comparison to the body weight prior to the initial treatment.

After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed.

After the treatments the participants will be followed for up to 6 months to assess the outcome of the GMA procedure.
Trial website
https://clinicaltrials.gov/study/NCT05587491
Trial related presentations / publications
Oberbach A, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Lehmann S, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization reduces adiposity and improves lipid and glucose metabolism in obese rats. Gastrointest Endosc. 2018 Jan;87(1):288-299.e6. doi: 10.1016/j.gie.2017.04.038. Epub 2017 May 4.
Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.
Fayad 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.
Oberbach A, Schlichting N, Kullnick Y, Heinrich M, Lehmann S, Retschlag U, Friedrich M, Fayad L, Dietrich A, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization improves blood pressure, renin and cardiovascular lipid deposition in a rat model of obesity. Endosc Int Open. 2019 Dec;7(12):E1605-E1615. doi: 10.1055/a-0990-9683. Epub 2019 Nov 25.
Itani MI, Oberbach A, Salimian KJ, Enderle M, Hahn H, Abbarh S, Kendrick K, Schlichting N, Anders RA, Besharati S, Farha J, Fayad L, Kalloo AN, Badurdeen D, Kumbhari V. Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach. Obes Surg. 2022 Feb;32(2):381-390. doi: 10.1007/s11695-021-05773-4. Epub 2021 Nov 19.
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Sartoretto, MBBS, BMedSc
Address 0 0
The Bariatric & Metabolic Institute The BMI Clinic, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Li Ping Ang
Address 0 0
Country 0 0
Phone 0 0
+65 8223 0369
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05587491