RECRUITING

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06543316

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects aged 18 years and above, inclusive of both males and females.
  2. * 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.
  3. * Subjects must be scheduled for an EGD for the evaluation of these symptoms.
  4. * Marginal ulcers confirmed during the initial EGD.
  5. * Willingness to adhere to the SOC treatment, which includes PPIs.
  6. * Subjects able to tolerate repeated endoscopic procedures.
  7. * Capacity for providing informed consent and understanding of study requirements.
  8. * Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).
  1. * Inability to provide informed consent.
  2. * Unwillingness to undergo repeated endoscopies.
  3. * Inability or unwillingness to comply with the SOC.
  4. * Current use of systemic antibiotics.
  5. * Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
  6. * Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
  7. * Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.

Contacts and Locations

Study Contact

Michele B Ryan, MS
CONTACT
617-525-8266
mryan@bwh.harvard.edu
Samantha Geltz
CONTACT
617-732-5174
sgeltz@bwh.harvard.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Christopher C. Thompson, MD, MSc

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-02
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • Argon Plasma Coagulation
  • APC
  • Low-Thermal Argon Plasma Endoscopic Treatment
  • Endoscopy
  • RYGB
  • Roux-en-Y Gastric Bypass
  • Ulcer Healing

Additional Relevant MeSH Terms

  • 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