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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Awards & highlights
C2D2 Trial 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.Check my eligibility
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.See study design
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.
C2D2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My FAP condition is classified as moderate to severe.
Select...
My polyps are flat or slightly raised, cover less than half the duodenum's width, and are on no more than 3 folds.
Select...
I have a non-hereditary growth in my small intestine that is 1 to 5 cm wide.
Select...
I am at high risk for surgery or have refused standard treatments.
C2D2 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in Spigelman class score
Median number of CryoBalloon treatments to complete eradication.
Duodenum
+4 moreC2D2 Trial Design
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)
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,603 Total Patients Enrolled
Pentax MedicalIndustry Sponsor
16 Previous Clinical Trials
1,446 Total Patients Enrolled
Marcia I. Canto, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I cannot stop my blood thinning medication for a procedure.My FAP condition is classified as moderate to severe.My esophageal cancer has not been treated yet.My polyps are flat or slightly raised, cover less than half the duodenum's width, and are on no more than 3 folds.My condition involves a lesion in the ampulla area.I have a non-hereditary growth in my small intestine that is 1 to 5 cm wide.I have or had swollen blood vessels in my esophagus or stomach.I've had a polyp removed via EMR or saline-assisted polypectomy that meets the study criteria.I have not had a polyp removal or EMR within the last 6 weeks.I am at high risk for surgery or have refused standard treatments.My scans show possible cancer in my abdomen.I have a narrowed area in my esophagus or stomach but it can be widened to 15mm.I have or might have cancer in the beginning of my small intestine.I have no ulcers, masses, or nodules near the treatment area.I have active inflammation in my duodenum.My lesion is classified as Paris 1p, 2c, or 3.
Research Study Groups:
This trial has the following groups:- Group 1: Familial Adenomatous Polyposis (FAP)
- Group 2: Sporadic duodenal adenomas
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate aim of this clinical experiment?
"This clinical trial, evaluated over a period of 5 years, will examine the security of cryoBalloon ablation in treating non-ampullary non-polypoid duodenal adenomas. The primary objective is to assess adverse events experienced by all participants. Other objectives include assessing any changes in Spigelman class score which denotes polyp burden severity; progression rate to high grade dysplasia or duodenal cancer; and % change in treated duodenal adenoma size using endoscopic assessment with an expert panel reviewing still images marked with region of interest tattoos."
Answered by AI
In how many distinct locales is this clinical investigation being conducted?
"At this moment in time, 8 medical sites are looking for individuals to take part in the trial. These locales stretch from Baltimore to Dallas and Danville among other cities. To reduce travel demands, it is recommended that you select a site closest to where you live."
Answered by AI
Is enrollment still open for participation in this research project?
"This investigation, which was initially posted on May 13th 2019 and last adjusted on July 7th 2022 is not presently accepting participants. Despite this fact, there are 86 other active research studies recruiting individuals at the moment."
Answered by AI
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