CryoBalloon Ablation for Duodenal Adenomas

(C2D2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called CryoBalloon Ablation, which uses cold energy to remove tissue, to determine its safety and effectiveness for treating certain types of duodenal adenomas, a benign tumor in the small intestine. The study focuses on both sporadic (randomly occurring) and familial (genetic) cases of non-polypoid (flat) duodenal adenomas. Individuals dealing with these duodenal growths, especially those at high risk for surgery or other treatments, might be suitable for this trial. Those identified by their doctors as high risk for standard treatments or who have these specific duodenal growths may find this study relevant. As an unphased trial, it offers the opportunity to explore a novel treatment option for those seeking alternatives to traditional methods.

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 prior data suggests that the CryoBalloon device is safe for treating duodenal adenomas?

Research has shown that cryoballoon ablation is generally safe for treating duodenal adenomas. In studies, this procedure used a special tool to freeze and remove abnormal tissue. Participants in these studies tolerated the treatment well, and no major safety issues arose. Some patients might experience mild discomfort, but serious side effects are rare. Cryoballoon ablation is considered safer than methods like endoscopic resection, which involves cutting out the tissue. This makes cryoballoon ablation a promising option for those considering clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

CryoBalloon Ablation is unique because it offers a novel approach to treating duodenal adenomas. Unlike the traditional endoscopic resection methods, which can be invasive and complex, CryoBalloon Ablation uses extreme cold to target and destroy abnormal tissue. This technique is minimally invasive and allows for precise targeting of the adenomas, potentially reducing recovery time and minimizing complications. Researchers are excited because this method could provide a safer and more efficient alternative to current treatment options, making it a promising advancement in the care of patients with both familial adenomatous polyposis (FAP) and sporadic duodenal adenomas.

What evidence suggests that CryoBalloon Ablation is effective for duodenal adenomas?

Research has shown that CryoBalloon Ablation holds promise for treating duodenal adenomas, which are growths in the small intestine. Early studies demonstrated that this treatment can effectively remove these growths. It has also succeeded in treating similar conditions, such as Barrett's esophagus, using the CryoBalloon method. This method freezes the abnormal tissue, allowing healthy tissue to regrow. Although more information is needed for a comprehensive understanding, early results suggest that CryoBalloon Ablation could safely and effectively remove duodenal adenomas. Participants in this trial will receive CryoBalloon Ablation, regardless of whether they have familial adenomatous polyposis (FAP) or sporadic duodenal adenomas. ^{2 3 4 6 7}

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 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]

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]

Citations

1. giejournal.org giejournal.org/article/S0016-5107(20)34554-5/fulltext

Cryoballoon ablation for duodenal adenomas For most nonampullary duodenal adenomas, EMR is effective (93% success rate for initial resection for nonampullary duodenal polyps vs 46% to 92% for ampullary ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510720343984

Initial multicenter experience with nitrous oxide cryoballoon ... However, the safety and efficacy outcomes of EMR have varied, with some studies reporting a high recurrence rate (14.4%-23%), 0% to 3% perforation rate, and 11 ...

3. ddw.digitellinc.com ddw.digitellinc.com/p/s/nitrous-oxide-cryoballoon-ablation-for-eradication-of-non-ampullary-sporadic-and-familial-duodenal-adenomas-preliminary-results-of-a-multicenter-clinical-trial-3629

NITROUS OXIDE CRYOBALLOON ABLATION FOR ERADICATION ... The aim of this study was to determine efficacy and clinical course of EUS-GJ in benign GOO. Methods: This was a single center retrospective series. Consecutive ...

4. trial.medpath.com trial.medpath.com/clinical-trial/c28db48fad16a485/nct03847636-safety-efficacy-cryoballoon-ablation-duodenal-adenomas

CryoBalloon Ablation for Treatment of Duodenal Adenomas Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's esophagus ( ...

5. clinicaltrial.be clinicaltrial.be/en/details/177285?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

CryoBalloon Ablation for Treatment of Duodenal ... Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's ...

6. ctv.veeva.com ctv.veeva.com/study/cryoballoon-ablation-for-treatment-of-duodenal-adenomas

CryoBalloon Ablation for Treatment of Duodenal Adenomas Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8259240/

Endoscopic management of duodenal adenomatosis in ... Endoscopic surveillance is recommended at 0.5‐ to 5‐year intervals depending on the extent of polyp growth and histological progression.