An interventional study of Low Thermal Plasma (LTP) Treatment and Standard of Care Ulcer Treatment (typically PPI Administration) in Roux-en-y Anastomosis Site, Marginal Ulcer and Marginal Ulcer (Peptic) or Erosion, sponsored by Christopher C. Thompson, MD, MSc. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Christopher C. Thompson, MD, MSc · Not applicable, Interventional, and Treatment
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.
Gastric bypass surgery, specifically Roux-en-Y gastric bypass (RYGB), is the second most common bariatric procedure performed worldwide (29.3%) after sleeve gastrectomy (55.4%). 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 0.6% to 25% in the U.S., 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 20°C and 50°C). 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 (e.g., 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, 1.5 mm, 2.3 mm and 3.2 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).
116 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's planned enrollment of 100 is below the median of 298 across 88 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →Christopher C. Thompson, MD, MSc is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Compared within Stomach Ulcer, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peptic Ulcer. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration).
Procedure: Low Thermal Plasma (LTP) Treatment · Other: Standard of Care Ulcer Treatment (typically PPI Administration)
Patients randomized to this group will receive only the SOC treatment (PPI administration).
Other: Standard of Care Ulcer Treatment (typically PPI Administration)
For patients randomized to the LTP group, the first LTP treatment will be administered during the initial esophagogastroduodenoscopy (EGD) using a single-use 2.3 mm filtered argon plasma coagulation (FiAPC probe). The argon plasma will be applied at low power settings (\~1 W) to the ulcerated areas using pulsed APC effect 0.1.
Also known as: LTP
Standard of care for treatment of ulcers is administration of a proton pump inhibitor (PPI). For patients in the SOC group whose ulcers have not healed completely by the second follow-up at 8 weeks, crossover to LTP treatment will be offered. This treatment will follow the same procedure as the initial LTP treatment.
Also known as: PPI
Ulcer Healing Success Rate from baseline endoscopy
Complete healing or significant reduction in ulcer size, determined by endoscopic evaluation at the first follow-up (4 weeks +/- 1 week) and at the end of the second follow-up period (8 weeks +/- 2 weeks).
Time frame: Baseline, 4 weeks, 8 Weeks
Comparison of Time to Ulcer Healing between LTP and SOC groups
To measure the time in days from initial treatment to complete ulcer healing in both treatment phases, accounting for the initial ulcer size.
Time frame: Baseline, 4 weeks, 8 weeks
Improvement of Tissue Oxygenation at Ulcer Site in LTP treatment group
To measure the change of the tissue oxygenation in the ulcerated area directly after the LTP treatment and at the follow-up visits. Level of tissue oxygenation will be compared to a baseline measurement before the initial LTP treatment. Level of tissue oxygenation measured by light absorption with an image sensor (ELUXEO Vision System, Fujifilm).
Time frame: Baseline, 4 weeks, 8 weeks
Presence of Procedure-Related Adverse Events
To evaluate the safety profile of LTP by recording the presence of adverse events such as bleeding, perforation, and infection in both initial and crossover phases from during the procedure up to 8 weeks post-procedure.
Time frame: Baseline, up to 8 weeks
Clinical Improvement of Gastrointestinal Symptoms
Change in Gastrointestinal Symptoms from Baseline Using the gastrointestinal symptom rating scale (GSRS). This has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame: Baseline, 8 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.
Time frame: Baseline, 8 Weeks
Plan to share: Yes — Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: 12 months after publication.
Access criteria: IPD requests should be made directly to the PI who will determine feasibility of the request. Institutional data transfer agreement will need to be executed to share data.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Christopher C. Thompson, MD, MSc