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CryoBalloon Ablation for Duodenal Adenomas (C2D2 Trial)
C2D2 Trial Summary
This trial will test whether a new treatment for duodenal adenomas is safe and effective.
C2D2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowC2D2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.C2D2 Trial Design
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Who is running the clinical trial?
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- I have had unsuccessful treatments with techniques like Argon Plasma, laser, or freezing.I have severe health issues that prevent me from undergoing endoscopy or that may limit my life to under 2 years.I have nodules or possible cancer found during an upper GI exam.I cannot stop my blood thinning medication for a procedure.My FAP condition is classified as moderate to severe.My esophageal cancer has not been treated yet.My polyps are flat or slightly raised, cover less than half the duodenum's width, and are on no more than 3 folds.My condition involves a lesion in the ampulla area.I have a non-hereditary growth in my small intestine that is 1 to 5 cm wide.I have or had swollen blood vessels in my esophagus or stomach.I've had a polyp removed via EMR or saline-assisted polypectomy that meets the study criteria.I have not had a polyp removal or EMR within the last 6 weeks.I am at high risk for surgery or have refused standard treatments.My scans show possible cancer in my abdomen.I have a narrowed area in my esophagus or stomach but it can be widened to 15mm.I have or might have cancer in the beginning of my small intestine.I have no ulcers, masses, or nodules near the treatment area.I have active inflammation in my duodenum.My lesion is classified as Paris 1p, 2c, or 3.
- Group 1: Familial Adenomatous Polyposis (FAP)
- Group 2: Sporadic duodenal adenomas
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the ultimate aim of this clinical experiment?
"This clinical trial, evaluated over a period of 5 years, will examine the security of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas. The primary objective is to assess adverse events experienced by all participants. Other objectives include assessing any changes in Spigelman class score which denotes polyp burden severity; progression rate to high grade dysplasia or duodenal cancer; and % change in treated duodenal adenoma size using endoscopic assessment with an expert panel reviewing still images marked with region of interest tattoos."
In how many distinct locales is this clinical investigation being conducted?
"At this moment in time, 8 medical sites are looking for individuals to take part in the trial. These locales stretch from Baltimore to Dallas and Danville among other cities. To reduce travel demands, it is recommended that you select a site closest to where you live."
Is enrollment still open for participation in this research project?
"This investigation, which was initially posted on May 13th 2019 and last adjusted on July 7th 2022 is not presently accepting participants. Despite this fact, there are 86 other active research studies recruiting individuals at the moment."
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