Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Description

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.

Conditions

Roux-en-y Anastomosis Site, Marginal Ulcer, Marginal Ulcer (Peptic) or Erosion, Ulcer, Ulcer, Gastric, Ulcer Gastrointestinal, Abdominal Pain, Nausea, Vomiting, GastroIntestinal Bleeding, Dysphagia, Ulcer Gastrojejunal

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Condition
Roux-en-y Anastomosis Site
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects aged 18 years and above, inclusive of both males and females.
  • * Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.
  • * Subjects must be scheduled for an EGD for the evaluation of these symptoms.
  • * Marginal ulcers confirmed during the initial EGD.
  • * Willingness to adhere to the SOC treatment, which includes PPIs.
  • * Subjects able to tolerate repeated endoscopic procedures.
  • * Capacity for providing informed consent and understanding of study requirements.
  • * Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).
  • * Inability to provide informed consent.
  • * Unwillingness to undergo repeated endoscopies.
  • * Inability or unwillingness to comply with the SOC.
  • * Current use of systemic antibiotics.
  • * Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
  • * Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
  • * Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Christopher C. Thompson, MD, MSc,

Christopher C. Thompson, MD, MSc, PRINCIPAL_INVESTIGATOR, Brigham and Womens Hospital

Study Record Dates

2027-04-30