44 Participants Needed

CryoBalloon Ablation for Duodenal Adenomas

(C2D2 Trial)

Recruiting at 7 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CryoBalloon Ablation has been used safely in humans for conditions like atrial fibrillation, with studies showing it has a safety profile comparable to other treatments and a lower rate of adverse events when using a single freeze strategy.678910

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

MI

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

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.
See 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.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryoballoon ablation treatment for duodenal adenomas

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

  • CryoBalloon Ablation
Trial Overview 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.
Participant Groups
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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Pentax Medical

Industry Sponsor

Trials
18
Recruited
1,600+

Findings from Research

In a study involving 30 patients with Barrett's esophagus, a 10-second cryoablation using the CryoBalloon successfully targeted 94% of the BE islands, demonstrating effective treatment precision.
Complete eradication of intestinal metaplasia and dysplasia was achieved in all areas that were completely ablated, with no reported complications such as stenoses, indicating a safe and effective intervention.
Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands.Künzli, HT., Schölvinck, DW., Meijer, SL., et al.[2018]
In a review of 320 adverse events related to cryoballoon catheter use for pulmonary vein isolation over 10.7 years, the most common issue was phrenic nerve palsy, occurring in 48% of cases, followed by cardiac perforation at 15%.
All reported intra-procedural deaths were linked to cardiac perforation, highlighting a significant safety concern associated with this procedure.
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience.Tan, MC., Tan, JL., Lee, WJ., et al.[2023]

References

Initial multicenter experience with nitrous oxide cryoballoon for treatment of flat duodenal adenomas (with video). [2021]
Pulmonary Vein Isolation Using the First-Generation Cryoballoon Technique in Chinese Patients. [2016]
Cryoablation of atrial fibrillation with the fourth-generation balloon: The first reported case. [2019]
Are routine cryoballoon procedural characteristics predictive of atrial arrhythmia recurrence in the long term? [2021]
Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands. [2018]
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience. [2023]
Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study. [2022]
Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry. [2022]
Fluoroscopic Appearance of a Single-Wall Cryoballoon Breach During Pulmonary Vein Isolation. [2021]
Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis. [2022]
Life-threatening pulmonary haemorrhage during cryoballoon ablation for atrial fibrillation. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Cryoballoon versus radiofrequency catheter ablation of paroxysmal atrial fibrillation: biomarkers of myocardial injury, recurrence rates, and pulmonary vein reconnection patterns. [2022]
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