Duodenal AdenomasC2D2NCT03847636
CryoBalloon Ablation for Treatment of Duodenal Adenomas
A study testing CryoBalloon ablation in people with Duodenal Adenomas and Familial Adenomatous Polyposis, run by Johns Hopkins University at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Adenomas, Familial Adenomatous Polyposis
- What is being tested?
- CryoBalloon ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 May 2019to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sporadic duodenal adenomas between 1 to 5 cm in widest diameter
- 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
- Individuals must be considered high risk for surgery or endoscopic resection, due to complication risk, or declined standard therapies.
- Prior endoscopic mucosal resection (EMR) or saline-assisted polypectomy allowed if polyp characteristics meet inclusion criteria.
Who cannot join
- Suspected or proven duodenal carcinoma
- Paris 1p pedunculated, Paris 2c, or 3 lesions
- Paris 1s lesion > 4 mm thick (estimated with closed biopsy forceps)
- Ampullary lesion or lesion involving the ampulla
- Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy
- Pre-existing esophageal, gastric, pyloric, or duodenal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline esophagogastroduodenoscopy (EGD.) Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed.
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- Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD within 3 cm of the treatment area.
- Subjects with nodular polyps or suspicion of invasive cancer by white light endoscopy /enhanced imaging/biopsy identified during screening/baseline EGD
- Suspicion of malignancy by abdominal or endoscopic ultrasound imaging based on malignant lymph nodes, invasion of lesion beyond mucosa.
- EMR or polypectomy < 6 weeks prior to baseline treatment.
- Untreated invasive esophageal malignancy, including margin-positive EMR.
- Active duodenitis in treatment zone during screening/baseline EGD.
- Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication per standards of the institutions performing cryoablation.
- Known portal hypertension, visible esophageal, gastric, or duodenal varices, or history of varices.
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
- Pregnant or planning to become pregnant during period of study participation.
- Patient refuses or is unable to provide written informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Methodist Dallas Medical Center
Dallas, Texas, 75203
Geisinger Medical Center
Danville, Pennsylvania, 17822
Northwell Health
Manhasset, New York, 11030
About this study
Official title: Safety and Efficacy of Cryoballoon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas (the C2D2 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.
Read the detailed description
Duodenal adenomas are precursors to adenocarcinoma. Treatment with endoscopic polypectomy is technically challenging problematic and associated with a high rate of complication - overall 26%, with bleeding 22-40%, higher with larger polyps. Surgery to remove these benign polyps would be a Whipple operation, which has a high morbidity and 1-4% mortality rate. Medical therapies like celecoxib decrease the number of polyps but do not prevent cancer.
This multicenter prospective cohort study will assess the safety and efficacy of cryoablation treatment as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas
Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's esophagus (including a clinical trial published by the Principal Investigator), which is intestinal metaplasia, which is histologically similar to normal duodenal mucosa.
When inflated, the cryoballoon flattens the duodenal folds allowing improved visibility of the duodenal lesions. The focal ablation allows precise targeting and avoidance of the ampulla to minimize pancreatitis risk.
Two cases at Johns Hopkins Hospital have been treated successfully and safely using cryogen dose of 10 seconds. The procedures were easy and short, with excellent views of the lesion with balloon inflation and high definition endoscope. No major adverse events, pain requiring treatment, or bleeding were noted. Minor adverse events included transient abdominal bloating lasting for < 3 days in 1 patient. In one patient with sporadic laterally spreading large Paris 2A polyp who declined standard treatments, complete eradication was achieved with 2 ablation sessions.
In the other patient with familial adenomatous polyposis (FAP) who had 2 hospitalizations for post-polypectomy bleeding after duodenal EMR, complete eradication was noted after 1 treatment of 3 Paris 2A and 2B adjacent polyps.
Follow-up of these two patients shows no recurrence > 1 year and at the most recent follow-up procedures. Clinical and endoscopic surveillance continues.
In addition, another physician at the University of Texas Health Science Center at San Antonio (UTHSCSA) reported another two patients with duodenal adenomas in her practice treated successfully with cryoballoon ablation without complications. Two other collaborating physicians at Memorial Hermann Texas Medical Center in Houston, Texas, and Geisinger Medical Center in Pennsylvania have also reported favorable response of these challenging neoplasms to endoscopic cryoballoon ablation. The group is currently preparing a case series report and a separate Institutional Review Board application is being submitted.
This study may impact on the management of patients with duodenal adenomas by demonstrating the potential for safe and effective non-operative eradication using cryoballoon ablation. The safety profile of endoscopic cryoballoon ablation is likely to be better than endoscopic resection based on a large clinical and research experience in Barrett's esophagus patients (>250) and small clinical experience in duodenal adenoma patients, with <=5% bleeding, no perforation, and transient, mild post-treatment discomfort.
- Conditions
- Duodenal Adenomas, Familial Adenomatous Polyposis
- Being tested
- CryoBalloon ablation
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoBalloon ablationDevice
Endoscopic cryoablation (cryogen is nitrous oxide) using a CryoBalloon catheter to ablate up to 4 separate DAs.
| Study group | Role | What they receive |
|---|---|---|
| cryoballoon ablation | Experimental | Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention), and individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention). Receives: Device: CryoBalloon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CryoBalloon Ablation in Treating Non-ampullary Non-polypoid Duodenal Adenomas (DAs) as Assessed by Participants With Adverse Events
To assess participants with any adverse event following cryoablation using the C2 cryoballoon system (per patient analysis). This includes serious adverse events (hospitalization, emergency room visit, bleeding requiring intervention) and post-procedure upper abdominal pain, nausea and gas-bloat
Measured: 1 year
Participants With Complete Eradication of DA
Complete eradication (CE) rate of DAs as assessed by a combination of endoscopic and pathologic absence of adenomatous tissue in treated areas.
Measured: 1 year
Secondary outcomes (5)
Technical Failure Rate
Technical failure rate is the number of patients with any treatment procedure of cryoballoon ablation that did not complete delivery of cryogen to all targeted sites.
Measured: 1 year
Progression to High Grade Dysplasia or Duodenal Cancer
Progression: Patients with progression of dysplasia grade to high grade dysplasia or invasive cancer, compared to baseline biopsies, at any time during the study.
Measured: 1 year
Number of Patients With Complete Eradication of All Eligible Treated DAs at 1 Year
Number of patients with duodenal adenomas with completely eradication of all eligible treated DAs at 1 year, combining FAP and sporadic DA patients
Measured: 1 year
Mean Number of CryoBalloon Treatments Per Patient to Achieve Complete Eradication of DAs
Mean number of CryoBalloon treatments for each patient to achieve complete eradication of all eligible treated DAs by one year
Measured: 1 year
Eligible Duodenal Adenomas Treated
duodenal adenomas measuring between 1cm-5cm treated with CryoBalloon ablation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start13 May 2019
- Primary completion1 Jun 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Duodenal AdenomasStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Non-randomized pilot study of highly selected patients
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Pentax Medical
- Responsible party
- Sponsor
- Investigators
- Marcia I. Canto, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847636
- Sponsor's protocol ID
- IRB00163804
- Acronym
- C2D2
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2019
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Submit request to P.I. and study team with study goal.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cryoballoon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas (the C2D2 Trial)
- ClinicalTrials.gov ID
- NCT03847636
- Acronym / sponsor ID
- C2D2 / IRB00163804
- Conditions
- Duodenal Adenomas, Familial Adenomatous Polyposis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Pentax Medical
- Study start
- 13 May 2019 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Duodenal adenomas are precursors to adenocarcinoma. Treatment with endoscopic polypectomy is technically challenging problematic and associated with a high rate of complication - overall 26%, with bleeding 22-40%, higher with larger polyps. Surgery to remove these benign polyps would be a Whipple operation, which has a high morbidity and 1-4% mortality rate. Medical therapies like celecoxib decrease the number of polyps but do not prevent cancer.
This multicenter prospective cohort study will assess the safety and efficacy of cryoablation treatment as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas
Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's esophagus (including a clinical trial published by the Principal Investigator), which is intestinal metaplasia, which is histologically similar to normal duodenal mucosa.
When inflated, the cryoballoon flattens the duodenal folds allowing improved visibility of the duodenal lesions. The focal ablation allows precise targeting and avoidance of the ampulla to minimize pancreatitis risk.
Two cases at Johns Hopkins Hospital have been treated successfully and safely using cryogen dose of 10 seconds. The procedures were easy and short, with excellent views of the lesion with balloon inflation and high definition endoscope. No major adverse events, pain requiring treatment, or bleeding were noted. Minor adverse events included transient abdominal bloating lasting for < 3 days in 1 patient. In one patient with sporadic laterally spreading large Paris 2A polyp who declined standard treatments, complete eradication was achieved with 2 ablation sessions.
In the other patient with familial adenomatous polyposis (FAP) who had 2 hospitalizations for post-polypectomy bleeding after duodenal EMR, complete eradication was noted after 1 treatment of 3 Paris 2A and 2B adjacent polyps.
Follow-up of these two patients shows no recurrence > 1 year and at the most recent follow-up procedures. Clinical and endoscopic surveillance continues.
In addition, another physician at the University of Texas Health Science Center at San Antonio (UTHSCSA) reported another two patients with duodenal adenomas in her practice treated successfully with cryoballoon ablation without complications. Two other collaborating physicians at Memorial Hermann Texas Medical Center in Houston, Texas, and Geisinger Medical Center in Pennsylvania have also reported favorable response of these challenging neoplasms to endoscopic cryoballoon ablation. The group is currently preparing a case series report and a separate Institutional Review Board application is being submitted.
This study may impact on the management of patients with duodenal adenomas by demonstrating the potential for safe and effective non-operative eradication using cryoballoon ablation. The safety profile of endoscopic cryoballoon ablation is likely to be better than endoscopic resection based on a large clinical and research experience in Barrett's esophagus patients (>250) and small clinical experience in duodenal adenoma patients, with <=5% bleeding, no perforation, and transient, mild post-treatment discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized pilot study of highly selected patients
| Arm | Type | Receives |
|---|---|---|
| cryoballoon ablation | Experimental | Device: CryoBalloon ablationIndividuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention), and individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sporadic duodenal adenomas between 1 to 5 cm in widest diameter
- 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
- Individuals must be considered high risk for surgery or endoscopic resection, due to complication risk, or declined standard therapies.
Key exclusion criteria (18 listed)
- Suspected or proven duodenal carcinoma
- Paris 1p pedunculated, Paris 2c, or 3 lesions
- Paris 1s lesion > 4 mm thick (estimated with closed biopsy forceps)
- Ampullary lesion or lesion involving the ampulla
- Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoBalloon ablationEndoscopic cryoablation (cryogen is nitrous oxide) using a CryoBalloon catheter to ablate up to 4 separate DAs. | Device | cryoballoon ablation |
Primary outcome
Safety of CryoBalloon Ablation in Treating Non-ampullary Non-polypoid Duodenal Adenomas (DAs) as Assessed by Participants With Adverse Events
Time frame: 1 year
To assess participants with any adverse event following cryoablation using the C2 cryoballoon system (per patient analysis). This includes serious adverse events (hospitalization, emergency room visit, bleeding requiring intervention) and post-procedure upper abdominal pain, nausea and gas-bloat
Participants With Complete Eradication of DA
Time frame: 1 year
Complete eradication (CE) rate of DAs as assessed by a combination of endoscopic and pathologic absence of adenomatous tissue in treated areas.
5 secondary outcomes
Technical Failure Rate
Time frame: 1 year
Progression to High Grade Dysplasia or Duodenal Cancer
Time frame: 1 year
Number of Patients With Complete Eradication of All Eligible Treated DAs at 1 Year
Time frame: 1 year
Mean Number of CryoBalloon Treatments Per Patient to Achieve Complete Eradication of DAs
Time frame: 1 year
Eligible Duodenal Adenomas Treated
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Submit request to P.I. and study team with study goal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia I. Canto, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CryoBalloon ablation in people with Duodenal Adenomas and Familial Adenomatous Polyposis, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CryoBalloon Ablation in Treating Non-ampullary Non-polypoid Duodenal Adenomas (DAs) as Assessed by Participants With Adverse Events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.