HybridAPC for Gastric Mucosal Ablation in Obese Patients.

NCT05587491 | Completed

• 1 other identifier: 2021_03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Adiposity

Keywords

Endoscopic bariatric therapy; Hybrid Argonplasma Coagulation

Outcome Measures

Primary Outcomes (1)

• Assessment of the % of total body weight loss (% TBWL).

  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.

  9 months

Study Arms (1)

Gastric mucosal ablation

OTHER

Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid argonplasma.

Device: Hybrid Argonplasma coagulation (HAPC)

Interventions

Hybrid Argonplasma coagulation (HAPC) DEVICE

Gastric mucosal ablation is an endoscopic procedure which uses argonplasma coagulation in combination with submucosal injection to achieve selective ablation

Gastric mucosal ablation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females patients in the range of class I to class III obesity (30 ≤ BMI ≤ 45).
• Age 21 - 75 yrs.
• Treatment naïve for bariatric surgery or endoscopic bariatric therapy
• 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 (WOCBP) must agree to use acceptable contraception methods.
• Agree not to donate blood during their participation in the study.
• Able to comply with study requirements and understand and sign the Informed Consent Form.
• Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to screening visit.

You may not qualify if:

• Patients requiring exogenous insulin.
• HbA1c \> 9.5 %
• Pregnant or breast-feeding or intending to get pregnant during the study.
• Unwilling or unable to complete the patient diary, or comply with study visits and other study procedures as required per protocol.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Probable insulin production failure, defined as fasting C-Peptide serum \< 1 ng/mL (333 pmol/l).
• Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).
• Change in diabetic treatment within the last three months.
• 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.
• Change of diabetes medication or doses 12 weeks prior to screening visit.
• 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).
• 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.
• Previous upper GI surgery, or other endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
• History of diabetic gastroparesis.
• Known active hepatitis or active liver disease.

Sponsors & Collaborators

• Erbe Elektromedizin GmbH: lead
• ERBE AUSTRALIA PTY LTD: collaborator

Study Sites (1)

The Bariatric & Metabolic Institute The BMI Clinic

Double Bay, New South Wales, 2028, Australia

Location

Related Publications (5)

• 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.

  PMID: 28479494 BACKGROUND

• 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.

  PMID: 29476845 BACKGROUND

• 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.

  PMID: 31788546 BACKGROUND

• 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.

  PMID: 31788541 BACKGROUND

• 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.

  PMID: 34797503 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Sartoretto, MBBS, BMedSc

  The Bariatric & Metabolic Institute The BMI Clinic, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: February 27, 2023
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

AU (1)