Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
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:
AMULET
Brief Summary:
The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting By a treatment of the ulcerated areas with argon plasma with low power settings 1 W we hypothesize that the size of the ulcers will shrink and the healing is accelerated compared to standard of care alone Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time From a societal and scientific perspective this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers duodenal ulcers and esophageal ulcers This advancement has the potential not only to improve patient outcomes through less invasive methods but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies
Detailed Description:
Gastric bypass surgery specifically Roux-en-Y gastric bypass RYGB is the second most common bariatric procedure performed worldwide 293 after sleeve gastrectomy 554 Despite its success in reducing obesity-related conditions RYGB is associated with the development of marginal ulcers MUs-internal wounds at the gastrojejunal anastomosis prone to poor healing The incidence of MUs in patients post-RYGB ranges widely reported at 06 to 25 in the US with some estimates as high as 34 worldwide due to asymptomatic cases that go undetected unless investigated endoscopically These ulcers can become chronic and persisting over time significantly complicating post-surgical outcomes and increasing the risk of severe complications like perforation which necessitates urgent surgical intervention in approximately 1-2 of cases
The current standard of care for MUs involves prolonged use of proton pump inhibitors PPIs which reduce gastric acidity to promote ulcer healing However this approach addresses only one aspect of MU pathophysiology and is limited by several shortcomings It is often insufficient in preventing recurrence and carries risks of significant side effects including increased risk of infection electrolyte imbalances and potential kidney disease particularly with long-term use Standard therapy is 8 weeks high-dose treatment and a lifelong PPI therapy is considered if success is seen with medical management For those not responding to 8 weeks of therapy most advocate for continued PPI treatment with serial endoscopic evaluation even up to 2 years out from initial diagnosis Given these challenges there is an evident need for alternative treatments that can more effectively target the underlying causes of MUs and reduce the reliance on PPIs
Low-thermal or low-temperature plasma LTP represents a significant advance in accelerated wound healing technologies As the fourth state of matter physical plasma is used in the field of plasma medicine to treat a variety of medical conditions at atmospheric pressure and temperatures close to body temperature typically between 20C and 50C Over the past 10 to 15 years wound healing has been a primary clinical application for LTP with extensive use demonstrating its clinical efficacy in the treatment of chronic and poorly healing wounds
The mechanisms by which LTP facilitates wound healing include oxygenation of tissues activation of growth factors improvement of microcirculation reduction of bacterial load in wounds and devitalization of senescent cells These effects are primarily achieved by the ionization of argon gas and the generation of reactive oxygen and nitrogen species RONS in the gas phase Clinically LTP has been applied to a variety of wound types including pressure ulcers chronic wounds and acute wounds and has demonstrated effectiveness across a range of wound sizes and stages LTP treatments are particularly noted for their ability to transform chronic wounds into actively healing wounds thereby altering the physiological state of the wound
Several studies have rigorously evaluated the safety profile of LTP and confirmed that it does not pose mutagenic or carcinogenic risks Long-term evaluations have shown no evidence of tumor formation or abnormal tissue architecture in gas plasma-treated animal models even after extended periods corresponding to 60 human-equivalent years Patient follow-up studies using advanced imaging techniques have further confirmed the absence of abnormal healing responses supporting the absence of adverse long-term effects
Currently the most common low-thermal plasma sources used to treat external wounds are PlasmaJets and Dielectric Barrier Discharge DBD plasma sources However the physical dimensions of these devices limit their use in endoscopic applications This has limited the availability of LTP for the treatment of internal wounds and ulcers
Argon plasma coagulation APC is a technology that has been used in endoscopy for more than three decades It has demonstrated clinical safety and efficacy in many areas including bleeding management eg bleeding ulcers ablation of cancerous tissue and precise treatment in sensitive areas It is primarily used in endoscopic procedures with flexible probes but also in laparoscopic and open surgery settings The flexible probes are available in various diameters 15 mm 23 mm and 32 mm
APC works by ionizing argon gas with a high-frequency alternating current passed through an electrode This ionized gas forms a physical plasma that is applied to tissue Depending on the mode and effect setting the plasma can be adjusted in power from as low as 1 W to as high as 120 W At higher power settings 5 W and above the plasma exhibits a more pronounced thermal effect due to increased current flow through the tissue facilitating effective coagulation Conversely at lower settings below 5 W a low-thermal plasma effect is achieved minimizing tissue coagulation through dynamic application and avoiding prolonged exposure to a single spot As with PlasmaJets and Dielectric Barrier Discharge DBD plasma sources the effectiveness of low-thermal argon plasma is primarily due to the high energy and voltage that generate reactive oxygen and nitrogen species RONS
The current standard of care for MUs involves prolonged use of proton pump inhibitors PPIs which reduce gastric acidity to promote ulcer healing However this approach addresses only one aspect of MU pathophysiology and is limited by several shortcomings It is often insufficient in preventing recurrence and carries risks of significant side effects including increased risk of infection electrolyte imbalances and potential kidney disease particularly with long-term use Standard therapy is 8 weeks high-dose treatment and a lifelong PPI therapy is considered if success is seen with medical management For those not responding to 8 weeks of therapy most advocate for continued PPI treatment with serial endoscopic evaluation even up to 2 years out from initial diagnosis Given these challenges there is an evident need for alternative treatments that can more effectively target the underlying causes of MUs and reduce the reliance on PPIs
Low-thermal or low-temperature plasma LTP represents a significant advance in accelerated wound healing technologies As the fourth state of matter physical plasma is used in the field of plasma medicine to treat a variety of medical conditions at atmospheric pressure and temperatures close to body temperature typically between 20C and 50C Over the past 10 to 15 years wound healing has been a primary clinical application for LTP with extensive use demonstrating its clinical efficacy in the treatment of chronic and poorly healing wounds
The mechanisms by which LTP facilitates wound healing include oxygenation of tissues activation of growth factors improvement of microcirculation reduction of bacterial load in wounds and devitalization of senescent cells These effects are primarily achieved by the ionization of argon gas and the generation of reactive oxygen and nitrogen species RONS in the gas phase Clinically LTP has been applied to a variety of wound types including pressure ulcers chronic wounds and acute wounds and has demonstrated effectiveness across a range of wound sizes and stages LTP treatments are particularly noted for their ability to transform chronic wounds into actively healing wounds thereby altering the physiological state of the wound
Several studies have rigorously evaluated the safety profile of LTP and confirmed that it does not pose mutagenic or carcinogenic risks Long-term evaluations have shown no evidence of tumor formation or abnormal tissue architecture in gas plasma-treated animal models even after extended periods corresponding to 60 human-equivalent years Patient follow-up studies using advanced imaging techniques have further confirmed the absence of abnormal healing responses supporting the absence of adverse long-term effects
Currently the most common low-thermal plasma sources used to treat external wounds are PlasmaJets and Dielectric Barrier Discharge DBD plasma sources However the physical dimensions of these devices limit their use in endoscopic applications This has limited the availability of LTP for the treatment of internal wounds and ulcers
Argon plasma coagulation APC is a technology that has been used in endoscopy for more than three decades It has demonstrated clinical safety and efficacy in many areas including bleeding management eg bleeding ulcers ablation of cancerous tissue and precise treatment in sensitive areas It is primarily used in endoscopic procedures with flexible probes but also in laparoscopic and open surgery settings The flexible probes are available in various diameters 15 mm 23 mm and 32 mm
APC works by ionizing argon gas with a high-frequency alternating current passed through an electrode This ionized gas forms a physical plasma that is applied to tissue Depending on the mode and effect setting the plasma can be adjusted in power from as low as 1 W to as high as 120 W At higher power settings 5 W and above the plasma exhibits a more pronounced thermal effect due to increased current flow through the tissue facilitating effective coagulation Conversely at lower settings below 5 W a low-thermal plasma effect is achieved minimizing tissue coagulation through dynamic application and avoiding prolonged exposure to a single spot As with PlasmaJets and Dielectric Barrier Discharge DBD plasma sources the effectiveness of low-thermal argon plasma is primarily due to the high energy and voltage that generate reactive oxygen and nitrogen species RONS
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