Helicobacter Pylori InfectionHEAPENCT06529159
H. Pylori Eradication With Argon Plasma During Endoscopy
A study testing HEAPE and Pre-HEAPE in people with Helicobacter Pylori Infection and Helicobacter Pylori, run by Christopher C. Thompson, MD, MSc at 1 site in United States.
Trial summary
The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori, Helicobacter Pylori Gastrointestinal Tract Infection
- What is being tested?
- HEAPE and Pre-HEAPE
- 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 siteUnited States
- Study dates
- 8 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years or older
- Confirmed untreated H. pylori infection
- Able to understand and sign informed consent
- Available to return for all routine follow-up study visits
- Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study.
Who cannot join
- Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.
- Pregnancy or puerperium
- Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
- Lactation
- An inability to provide informed consent
- Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.
- Hernias / aspiration risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele B. Ryan, MS, 6175258266, mryan@bwh.harvard.edu
Christopher C. Thompson, MD, MSc
About this study
Official title: H. Pylori Eradication With Argon Plasma During Endoscopy (HEAPE)
The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible.
Two different PAL generation modalities will be compared in this study:
Read more
- HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.
- Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.
To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test.
After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated.
This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.
Read the detailed description
Helicobacter pylori (H. pylori) is a prevalent bacterial infection that colonizes the gastric mucosa, affecting approximately 50% of the global population. Classified by the WHO as a class 1 carcinogen in 1994 and further supported by extensive evidence, H. pylori is recognized as a leading cause of ulcers and a significant risk factor for the development of gastric cancer. Despite a slight decline in the prevalence of H. pylori infection in developed countries, the absolute number of infected individuals in the U.S. remains alarmingly high at approximately 36% of the U.S. population. Gastric cancer, associated with H. pylori infection, continues to be a major health concern worldwide, accounting for over 1.1 million new cases and approximately 770,000 deaths each year. The causal link between H. pylori infection and nearly 90% of gastric cancer cases underscores the critical importance of effective eradication strategies.
Current treatments for H. pylori infection, which typically consist of triple or quadruple therapy combining two or three antibiotics with proton pump inhibitors (PPIs), are successful in approximately 80% of cases. This leaves a significant proportion of cases unresolved. In addition, the emergence of multidrug-resistant H. pylori strains, particularly those resistant to clarithromycin and quinolones, challenges these conventional approaches. The broader issue of increasing antibiotic resistance, leads to a reliance on back-up antibiotics for cases where standard treatments fail. A sharp decline of eradication rates during the last decade, underscores the need for alternative therapeutic strategies. A recent study estimated the total cost of H. pylori treatment failure to be over $5.3 billion in the U.S., primarily due to hospitalizations, medications, and outpatient visits for complications such as peptic ulcer disease and non-cardia gastric cancer. Research into treatments beyond antibiotics is needed to address the growing risk of resistance and to ensure sustainable, effective solutions for H. pylori infection.
The field of plasma medicine, particularly through the use of Argon Plasma Coagulation (APC), offers promising new avenues for addressing this challenge. APC, a technology with over 30 years of clinical safety and efficacy, has been utilized for bleeding management, ablation of cancerous tissues, and precise treatments in sensitive areas. More recently, it has shown good efficacy in the treatment of cervical intraepithelial lesions (CIN) at lower power levels with no visible macroscopic thermal effect. Recent advancements in plasma medicine have highlighted the antibacterial properties of physical plasma. It has demonstrated remarkable efficacy in wound healing by effectively eradicating bacterial infections, including those resistant to antibiotics. The effect of non-thermal plasma treatment is based on the high energy and voltage of the plasma, which generates reactive oxygen and nitrogen species (RONS), an electric field that can cause electroporative effects, and UV light emitted in the plasma.
These effects are present when plasma is applied directly to the site of action, but also when a liquid medium such as sodium chloride solution is used as a buffer substance. This concept of indirect plasma treatment is often referred to as Plasma Activated Liquid (PAL). In proprietary preclinical studies, PAL generated with APC probes using forced APC Effect 8 has been shown to achieve a 5-log reduction in H. pylori (SK225) after 15 minutes incubation. In a multidrug resistant E. coli 4MRGN stain (VC8874), a 6-log reduction was achieved after 15 minutes incubation.
This demonstrates that PAL harnesses the antimicrobial properties of plasma in a non-thermal, liquid-based approach. This innovative approach allows the effects of plasma to be applied to large surface areas, such as the gastric mucosa, offering a potentially effective treatment for H. pylori infection without the drawbacks associated with antibiotic resistance. The established safety record of APC and the common use of liquids as irrigation or injection solutions in endoscopy provide a solid foundation for its potential applications in the treatment of H. pylori infection.
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori, Helicobacter Pylori Gastrointestinal Tract Infection, H. Pylori Infection, H. Pylori Gastrointestinal Disease
- Being tested
- HEAPE, Pre-HEAPE
- Keywords
- Urea Breath Test, Argon Plasma Coagulation (APC), Endoscopy, Plasma Activated Liquid (PAL), Plasma Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEAPEProcedure or surgery
Also called Endoscopic APC Treatment in vivo
The stomach is filled with sodium chloride solution which is then treated with APC to activate it into an antibacterial solution.
Pre-HEAPEProcedure or surgery
Also called Plasma Activated Liquid (PAL) Administration
Plasma activated sodium chloride solution (prepared outside of the body) is administered into the patients stomach through an endoscope channel using a syringe.
| Study group | Role | What they receive |
|---|---|---|
| HEAPE direct | Active comparator | This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. Receives: Procedure: HEAPE |
| Pre-HEAPE | Active comparator | This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. Receives: Procedure: Pre-HEAPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test
Change in measurement H. pylori metabolic activity using the Urea Breath Test (UBT) 1 (+2/-0) day before and 2 (+18/-0) hours after treatment
Measured: Baseline, 2 hours post-treatment
Secondary outcomes (8)
Eradication of H. pylori load from 2 hours after treatment to 4 weeks after treatment using Urea Breath Test
- pylori eradication (negative UBT) directly after the HEAPE treatment (timepoint 1) and 4 (+2/-0) weeks after HEAPE treatment (timepoint 2)
Measured: 2 hours post-treatment, 4 weeks post-treatment
Comparison of H. pylori eradication rate between HEAPE + standard of care antibiotic treatment vs standard of care treatment (antibiotics) alone (historical data)
Comparison of eradication rates at 4 weeks between patients treated with HEAPE + antibiotics vs. published literature using UBT values
Measured: 4 weeks
Comparison of reduction in H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 2 hours post-treatment
Comparison of the reduction in H. pylori load, as measured by Urea Breath Test (UBT), 2 (+18/-0) hours after treatment between the HEAPE direct modality and the Pre-HEAPE modality
Measured: Baseline, 2 hours post-treatment
Comparison of H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 4 weeks post-treatment
Comparison of the reduction in H. pylori load, as measured by Urea Breath Test (UBT), 4 weeks after treatment between the HEAPE direct modality and the Pre-HEAPE modality
Measured: Baseline, 4 weeks post-treatment
Change in dyspepsia symptoms from baseline via patient self-report of symptoms
Change in patient self-report of dyspepsia symptoms from baseline up to 4 weeks post-treatment
Measured: Baseline, 4 weeks
Change in epigastric pain level from baseline via patient self-report of symptoms using the Abdominal Pain Index
Change in patient self-report of epigastric pain level from baseline up to 4 weeks post-treatment using Abdominal Pain Index (from no pain (0) to the most pain possible (10)).
Measured: Baseline, 4 weeks
Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12)
Comparison of quality of life scores from baseline to 4 weeks post-treatment using the SF-12 scoring system. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less has been recommended as a cut-off to determine a physical condition in the Physical Health Composite Score (PCS) section; while a score of 42 or less may be indicative of 'clinical depression' Mental Health Composite Score (MCS) section.
Measured: Baseline, 4 weeks
Adverse Events intra-procedural and post-treatment
Presence of adverse events that develop post-procedure
Measured: Intra-procedure, 2 hours post-treatment, 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start8 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, randomized, pilot, single-center, prospective clinical study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher C. Thompson, MD, MSc
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Sponsor-investigator, Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital
- Investigators
- Christopher C Thompson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529159
- Sponsor's protocol ID
- 2024P002031
- Acronym
- HEAPE
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared on a case by case basis with an Institutional data transfer agreement in place.
Publications
Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
PubMed 28456631Wang C, Yuan Y, Hunt RH. The association between Helicobacter pylori infection and early gastric cancer: a meta-analysis. Am J Gastroenterol. 2007 Aug;102(8):1789-98. doi: 10.1111/j.1572-0241.2007.01335.x. Epub 2007 May 23.
PubMed 17521398Mrochen DM, Miebach L, Skowski H, Bansemer R, Drechsler CA, Hofmanna U, Hein M, Mamat U, Gerling T, Schaible U, von Woedtke T, Bekeschus S. Toxicity and virucidal activity of a neon-driven micro plasma jet on eukaryotic cells and a coronavirus. Free Radic Biol Med. 2022 Oct;191:105-118. doi: 10.1016/j.freeradbiomed.2022.08.026. Epub 2022 Aug 28.
PubMed 36041652Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.
PubMed 33004546Cavaleiro-Pinto M, Peleteiro B, Lunet N, Barros H. Helicobacter pylori infection and gastric cardia cancer: systematic review and meta-analysis. Cancer Causes Control. 2011 Mar;22(3):375-87. doi: 10.1007/s10552-010-9707-2. Epub 2010 Dec 24.
PubMed 21184266Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
PubMed 22491499Argueta EA, Alsamman MA, Moss SF, D'Agata EMC. Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology. 2021 May;160(6):2181-2183.e1. doi: 10.1053/j.gastro.2021.02.014. Epub 2021 Feb 9. No abstract available.
PubMed 33577874Shiota S, Reddy R, Alsarraj A, El-Serag HB, Graham DY. Antibiotic Resistance of Helicobacter pylori Among Male United States Veterans. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1616-24. doi: 10.1016/j.cgh.2015.02.005. Epub 2015 Feb 11.
PubMed 25681693Megraud F, Graham DY, Howden CW, Trevino E, Weissfeld A, Hunt B, Smith N, Leifke E, Chey WD. Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe. Am J Gastroenterol. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.
PubMed 36191284Shah S, Hubscher E, Pelletier C, Jacob R, Vinals L, Yadlapati R. Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure. Expert Rev Gastroenterol Hepatol. 2022 Apr;16(4):341-357. doi: 10.1080/17474124.2022.2056015. Epub 2022 Apr 1.
PubMed 35315732Zenker M. Argon plasma coagulation. GMS Krankenhhyg Interdiszip. 2008 Nov 3;3(1):Doc15.
PubMed 20204117Eickhoff A, Jakobs R, Schilling D, Hartmann D, Weickert U, Enderle MD, Eickhoff JC, Riemann JF. Prospective nonrandomized comparison of two modes of argon beamer (APC) tumor desobstruction: effectiveness of the new pulsed APC versus forced APC. Endoscopy. 2007 Jul;39(7):637-42. doi: 10.1055/s-2007-966571.
PubMed 17611919Kwan V, Bourke MJ, Williams SJ, Gillespie PE, Murray MA, Kaffes AJ, Henriquez MS, Chan RO. Argon plasma coagulation in the management of symptomatic gastrointestinal vascular lesions: experience in 100 consecutive patients with long-term follow-up. Am J Gastroenterol. 2006 Jan;101(1):58-63. doi: 10.1111/j.1572-0241.2006.00370.x.
PubMed 16405534Vargo JJ. Clinical applications of the argon plasma coagulator. Gastrointest Endosc. 2004 Jan;59(1):81-8. doi: 10.1016/s0016-5107(03)02296-x. No abstract available.
PubMed 14722558Grund KE, Straub T, Farin G. New haemostatic techniques: argon plasma coagulation. Baillieres Best Pract Res Clin Gastroenterol. 1999 Apr;13(1):67-84. doi: 10.1053/bega.1999.0009.
PubMed 11030635
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H. Pylori Eradication With Argon Plasma During Endoscopy (HEAPE)
- ClinicalTrials.gov ID
- NCT06529159
- Acronym / sponsor ID
- HEAPE / 2024P002031
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori, Helicobacter Pylori Gastrointestinal Tract Infection, H. Pylori Infection, H. Pylori Gastrointestinal Disease
- Keywords
- Urea Breath Test, Argon Plasma Coagulation (APC), Endoscopy, Plasma Activated Liquid (PAL), Plasma Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Christopher C. Thompson, MD, MScUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jul 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.
The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible.
Two different PAL generation modalities will be compared in this study:
- HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.
- Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.
To evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test.
After the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated.
This two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.
Detailed description
Helicobacter pylori (H. pylori) is a prevalent bacterial infection that colonizes the gastric mucosa, affecting approximately 50% of the global population. Classified by the WHO as a class 1 carcinogen in 1994 and further supported by extensive evidence, H. pylori is recognized as a leading cause of ulcers and a significant risk factor for the development of gastric cancer. Despite a slight decline in the prevalence of H. pylori infection in developed countries, the absolute number of infected individuals in the U.S. remains alarmingly high at approximately 36% of the U.S. population. Gastric cancer, associated with H. pylori infection, continues to be a major health concern worldwide, accounting for over 1.1 million new cases and approximately 770,000 deaths each year. The causal link between H. pylori infection and nearly 90% of gastric cancer cases underscores the critical importance of effective eradication strategies.
Current treatments for H. pylori infection, which typically consist of triple or quadruple therapy combining two or three antibiotics with proton pump inhibitors (PPIs), are successful in approximately 80% of cases. This leaves a significant proportion of cases unresolved. In addition, the emergence of multidrug-resistant H. pylori strains, particularly those resistant to clarithromycin and quinolones, challenges these conventional approaches. The broader issue of increasing antibiotic resistance, leads to a reliance on back-up antibiotics for cases where standard treatments fail. A sharp decline of eradication rates during the last decade, underscores the need for alternative therapeutic strategies. A recent study estimated the total cost of H. pylori treatment failure to be over $5.3 billion in the U.S., primarily due to hospitalizations, medications, and outpatient visits for complications such as peptic ulcer disease and non-cardia gastric cancer. Research into treatments beyond antibiotics is needed to address the growing risk of resistance and to ensure sustainable, effective solutions for H. pylori infection.
The field of plasma medicine, particularly through the use of Argon Plasma Coagulation (APC), offers promising new avenues for addressing this challenge. APC, a technology with over 30 years of clinical safety and efficacy, has been utilized for bleeding management, ablation of cancerous tissues, and precise treatments in sensitive areas. More recently, it has shown good efficacy in the treatment of cervical intraepithelial lesions (CIN) at lower power levels with no visible macroscopic thermal effect. Recent advancements in plasma medicine have highlighted the antibacterial properties of physical plasma. It has demonstrated remarkable efficacy in wound healing by effectively eradicating bacterial infections, including those resistant to antibiotics. The effect of non-thermal plasma treatment is based on the high energy and voltage of the plasma, which generates reactive oxygen and nitrogen species (RONS), an electric field that can cause electroporative effects, and UV light emitted in the plasma.
These effects are present when plasma is applied directly to the site of action, but also when a liquid medium such as sodium chloride solution is used as a buffer substance. This concept of indirect plasma treatment is often referred to as Plasma Activated Liquid (PAL). In proprietary preclinical studies, PAL generated with APC probes using forced APC Effect 8 has been shown to achieve a 5-log reduction in H. pylori (SK225) after 15 minutes incubation. In a multidrug resistant E. coli 4MRGN stain (VC8874), a 6-log reduction was achieved after 15 minutes incubation.
This demonstrates that PAL harnesses the antimicrobial properties of plasma in a non-thermal, liquid-based approach. This innovative approach allows the effects of plasma to be applied to large surface areas, such as the gastric mucosa, offering a potentially effective treatment for H. pylori infection without the drawbacks associated with antibiotic resistance. The established safety record of APC and the common use of liquids as irrigation or injection solutions in endoscopy provide a solid foundation for its potential applications in the treatment of H. pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, randomized, pilot, single-center, prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| HEAPE direct | Active comparator | Procedure: HEAPEThis modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach. |
| Pre-HEAPE | Active comparator | Procedure: Pre-HEAPEThis modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be 18 years or older
- Confirmed untreated H. pylori infection
- Able to understand and sign informed consent
- Available to return for all routine follow-up study visits
- Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study.
Key exclusion criteria (7 listed)
- Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.
- Pregnancy or puerperium
- Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
- Lactation
- An inability to provide informed consent
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 |
|---|---|---|
| HEAPEAlso: Endoscopic APC Treatment in vivoThe stomach is filled with sodium chloride solution which is then treated with APC to activate it into an antibacterial solution. | Procedure or surgery | HEAPE direct |
| Pre-HEAPEAlso: Plasma Activated Liquid (PAL) AdministrationPlasma activated sodium chloride solution (prepared outside of the body) is administered into the patients stomach through an endoscope channel using a syringe. | Procedure or surgery | Pre-HEAPE |
Primary outcome
Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test
Time frame: Baseline, 2 hours post-treatment
Change in measurement H. pylori metabolic activity using the Urea Breath Test (UBT) 1 (+2/-0) day before and 2 (+18/-0) hours after treatment
8 secondary outcomes
Eradication of H. pylori load from 2 hours after treatment to 4 weeks after treatment using Urea Breath Test
Time frame: 2 hours post-treatment, 4 weeks post-treatment
Comparison of H. pylori eradication rate between HEAPE + standard of care antibiotic treatment vs standard of care treatment (antibiotics) alone (historical data)
Time frame: 4 weeks
Comparison of reduction in H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 2 hours post-treatment
Time frame: Baseline, 2 hours post-treatment
Comparison of H. pylori load measured by UBT HEAPE vs. Pre-HEAPE treatment arms from baseline to 4 weeks post-treatment
Time frame: Baseline, 4 weeks post-treatment
Change in dyspepsia symptoms from baseline via patient self-report of symptoms
Time frame: Baseline, 4 weeks
Change in epigastric pain level from baseline via patient self-report of symptoms using the Abdominal Pain Index
Time frame: Baseline, 4 weeks
Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12)
Time frame: Baseline, 4 weeks
Adverse Events intra-procedural and post-treatment
Time frame: Intra-procedure, 2 hours post-treatment, 4 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 28456631Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.
- Background: PubMed 17521398Wang C, Yuan Y, Hunt RH. The association between Helicobacter pylori infection and early gastric cancer: a meta-analysis. Am J Gastroenterol. 2007 Aug;102(8):1789-98. doi: 10.1111/j.1572-0241.2007.01335.x. Epub 2007 May 23.
- Background: PubMed 36041652Mrochen DM, Miebach L, Skowski H, Bansemer R, Drechsler CA, Hofmanna U, Hein M, Mamat U, Gerling T, Schaible U, von Woedtke T, Bekeschus S. Toxicity and virucidal activity of a neon-driven micro plasma jet on eukaryotic cells and a coronavirus. Free Radic Biol Med. 2022 Oct;191:105-118. doi: 10.1016/j.freeradbiomed.2022.08.026. Epub 2022 Aug 28.
- Background: PubMed 33004546Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.
- Background: PubMed 21184266Cavaleiro-Pinto M, Peleteiro B, Lunet N, Barros H. Helicobacter pylori infection and gastric cardia cancer: systematic review and meta-analysis. Cancer Causes Control. 2011 Mar;22(3):375-87. doi: 10.1007/s10552-010-9707-2. Epub 2010 Dec 24.
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- Background: PubMed 33577874Argueta EA, Alsamman MA, Moss SF, D'Agata EMC. Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology. 2021 May;160(6):2181-2183.e1. doi: 10.1053/j.gastro.2021.02.014. Epub 2021 Feb 9. No abstract available.
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- Background: PubMed 36191284Megraud F, Graham DY, Howden CW, Trevino E, Weissfeld A, Hunt B, Smith N, Leifke E, Chey WD. Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe. Am J Gastroenterol. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.
- Background: PubMed 35315732Shah S, Hubscher E, Pelletier C, Jacob R, Vinals L, Yadlapati R. Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure. Expert Rev Gastroenterol Hepatol. 2022 Apr;16(4):341-357. doi: 10.1080/17474124.2022.2056015. Epub 2022 Apr 1.
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- Individual participant dataSharing planned: Yes. IPD will be shared on a case by case basis with an Institutional data transfer agreement in place.
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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.
Christopher C Thompson, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEAPE and Pre-HEAPE in people with Helicobacter Pylori Infection and Helicobacter Pylori, run by Christopher C. Thompson, MD, MSc 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Ryan, MS (617-525-8266, mryan@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test (time frame: Baseline, 2 hours post-treatment). 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 NCT06529159, which also lists 30 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 Mar 2026.