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Cryoablation

CryoBalloon Ablation for Duodenal Adenomas (C2D2 Trial)

N/A

Waitlist Available

Led By Marcia I. Canto, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FAP patient with Spigelman class 2, 3 or 4 (see definition below)

Polyp characteristics: Non-polypoid lesions Paris 2A and 2B, or Sessile adenomas, occupying no more than 50% circumference of duodenum, and no more than 3 duodenal folds

Must not have

Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy

Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new treatment for duodenal adenomas is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of CryoBalloon ablation aren't listed here, similar procedures may cause abdominal pain, bleeding at the treatment site, potential damage to surrounding tissues or structures in the digestive tract and risks associated with sedation used during endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My FAP condition is classified as moderate to severe.

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

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

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I am at high risk for surgery or have refused standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had unsuccessful treatments with techniques like Argon Plasma, laser, or freezing.

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I have severe health issues that prevent me from undergoing endoscopy or that may limit my life to under 2 years.

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I have nodules or possible cancer found during an upper GI exam.

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My esophageal cancer has not been treated yet.

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My condition involves a lesion in the ampulla area.

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I have or had swollen blood vessels in my esophagus or stomach.

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I have not had a polyp removal or EMR within the last 6 weeks.

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My scans show possible cancer in my abdomen.

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I have a narrowed area in my esophagus or stomach but it can be widened to 15mm.

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I have or might have cancer in the beginning of my small intestine.

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I have no ulcers, masses, or nodules near the treatment area.

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I have active inflammation in my duodenum.

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My lesion is classified as Paris 1p, 2c, or 3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year, 2 years, 3 years, 4 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year, 2 years, 3 years, 4 years, 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year, 2 years, 3 years, 4 years, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete eradication rate of DAs

Safety of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas (DAs) as assessed by the incidence of adverse events in all treated patients

Safety of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas (DAs) as assessed by the incidence of adverse events in all treatment procedures

Secondary study objectives

Change in Spigelman class score

Median number of CryoBalloon treatments to complete eradication.

Duodenum

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