CryoBalloon Ablation for Duodenal Adenomas
(C2D2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have an uncontrolled bleeding disorder or cannot stop taking blood thinners as per the trial's standards.
What data supports the effectiveness of the treatment CryoBalloon Ablation for duodenal adenomas?
CryoBalloon Ablation has been shown to effectively treat Barrett's esophagus by completely eradicating abnormal tissue in targeted areas, suggesting it may also be effective for duodenal adenomas. Additionally, CryoBalloon Ablation has been used successfully in other conditions like atrial fibrillation, indicating its potential as a reliable treatment method.12345
Is CryoBalloon Ablation generally safe for humans?
How does CryoBalloon Ablation treatment for duodenal adenomas differ from other treatments?
CryoBalloon Ablation is unique because it uses a balloon filled with cold gas to freeze and destroy abnormal tissue, offering a less invasive option compared to traditional endoscopic mucosal resection (EMR), which has a higher risk of complications. This method has been effective in treating similar conditions like Barrett's esophagus, making it a promising alternative for duodenal adenomas.1591112
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.
Research Team
Marcia Canto, MD
Principal Investigator
Johns Hopkins University
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cryoballoon ablation treatment for duodenal adenomas
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CryoBalloon Ablation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Pentax Medical
Industry Sponsor