CryoBalloon Ablation for Duodenal Adenomas
(C2D2 Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byMarcia Canto, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas.

Eligibility Criteria

This trial is for individuals with duodenal adenomas that are 1-5 cm wide, high-risk for surgery, or who declined standard treatments. It's open to those who've had prior endoscopic resections if the polyp fits criteria and FAP patients with Spigelman class 2-4. Exclusions include suspected carcinoma, recent EMR/polypectomy, severe comorbidities, untreated invasive malignancies nearby, uncontrolled coagulopathy, general poor health or pregnancy.

Inclusion Criteria

My FAP condition is classified as moderate to severe.

My polyps are flat or slightly raised, cover less than half the duodenum's width, and are on no more than 3 folds.

I have a non-hereditary growth in my small intestine that is 1 to 5 cm wide.

+2 more

Exclusion Criteria

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.

+15 more

Participant Groups

The study tests CryoBalloon ablation using the C2 device as a primary treatment for nonampullary flat duodenal adenomas. This multicenter trial aims to determine how safe and effective this method is compared to traditional therapies.

2Treatment groups

Active Control

Group I: Familial Adenomatous Polyposis (FAP)Active Control1 Intervention

Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention)

Group II: Sporadic duodenal adenomasActive Control1 Intervention

Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention)