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New treatment option for Roux-en-y Anastomosis Site
Official title Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
ClinicalTrials.gov ID: NCT06543316
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- people 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.
You likely can't join if
- 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.
See the full eligibility criteria
- people 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.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.