Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529159
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
H Pylori Eradication With Argon Plasma During Endoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
H Pylori Eradication With Argon Plasma During Endoscopy HEAPE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAPE
Brief 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 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
1 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
2 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
Two different PAL generation modalities will be compared in this study
1 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
2 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 US remains alarmingly high at approximately 36 of the US population Gastric cancer associated with H pylori infection continues to be a major health concern worldwide accounting for over 11 million new cases and approximately 770000 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 53 billion in the US 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
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 53 billion in the US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None