CryoBalloon Ablation for Duodenal Adenomas

(C2D2 Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, Stenosis, Varices, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

44 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{6 9 10 11 12}

Who Is on the Research Team?

Marcia Canto, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Familial Adenomatous Polyposis (FAP) Active Control 1 Intervention

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

Group II: Sporadic duodenal adenomas Active Control 1 Intervention

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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Initial multicenter experience with nitrous oxide cryoballoon for treatment of flat duodenal adenomas (with video). [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pulmonary Vein Isolation Using the First-Generation Cryoballoon Technique in Chinese Patients. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Cryoablation of atrial fibrillation with the fourth-generation balloon: The first reported case. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Are routine cryoballoon procedural characteristics predictive of atrial arrhythmia recurrence in the long term? [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the CryoBalloon Focal Ablation System for the eradication of dysplastic Barrett's esophagus islands. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Fluoroscopic Appearance of a Single-Wall Cryoballoon Breach During Pulmonary Vein Isolation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Life-threatening pulmonary haemorrhage during cryoballoon ablation for atrial fibrillation. [2019]

12. United States pubmed.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]