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ObesityNCT05587491

HybridAPC for Gastric Mucosal Ablation in Obese Patients.

A study testing Hybrid Argonplasma coagulation (HAPC) in people with Obesity and Adiposity, run by Erbe Elektromedizin GmbH at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Obesity, Adiposity
What is being tested?
Hybrid Argonplasma coagulation (HAPC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteAustralia
Study dates
27 Feb 2023to 15 Apr 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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.
  • Acute gastrointestinal illness in the previous 7 days.
  • Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
  • 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.
  • 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.
  • 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.
  • 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.
  • Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting.
  • 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).
  • History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
  • Current use of anticoagulation therapy
  • Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure
  • 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.
  • Use of drugs known to affect GI motility (e.g. Metoclopramide).
  • Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine or over the counter weight loss medications at screening.
  • 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.
  • Persistent Anemia, defined as Hemoglobin <10 g/dL.
  • Subjects who have donated blood or received a transfusion in the prior 3 months.
  • Subjects with conditions that alter red blood cell turnover.
  • 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.
  • Active systemic infection.
  • Active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
  • Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
  • Not a candidate for surgery or general anesthesia.
  • Active illicit substance abuse or alcoholism.
  • Current smoker or smoking history in the last six months.
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
  • Other medical condition that does not allow for endoscopic procedure.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Bariatric & Metabolic Institute The BMI Clinic

    Double Bay, New South Wales, 2028

Other trials in Australia

About this study

Official title: Feasibility and Safety of HybridAPC for Gastric Mucosal Ablation in the Management of Patients With Obesity.

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.

Read more

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
Being tested
Hybrid Argonplasma coagulation (HAPC)
Keywords
Endoscopic bariatric therapy, Hybrid Argonplasma Coagulation
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05587491
Study groupRoleWhat they receive
Gastric mucosal ablationOtherParticipants receive submucosal injection followed by ablation of gastric mucosa using Hybrid argonplasma.
Receives: Device: Hybrid Argonplasma coagulation (HAPC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start27 Feb 2023
  3. Primary completion15 Apr 2025
  4. Study completion15 Apr 2025

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05587491
Sponsor's protocol ID
2021_03
Status last verified
Oct 2025
First submitted
17 Oct 2022
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28479494

  • 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.

    PubMed 29476845

  • 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.

    PubMed 31788546

  • 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.

    PubMed 31788541

  • 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.

    PubMed 34797503

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid Argonplasma coagulation (HAPC) in people with Obesity and Adiposity, run by Erbe Elektromedizin GmbH at 1 site in Australia.

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 45 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: finished, as of the sponsor's last update on 2 Oct 2025. 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 Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of the % of total body weight loss (% TBWL). (time frame: 9 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 NCT05587491, which also lists 5 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 2 Oct 2025.

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