Clinical trial · Interventional
CryoBalloon Ablation for Treatment of Duodenal Adenomas
Safety and Efficacy of Cryoballoon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas (the C2D2 Trial)
NCT03847636CI-TRIAL-00120738C2D2completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duodenal Adenomas | — | UNRESOLVED | — |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoBalloon ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cryoballoon ablation
- description
- 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).
- interventionNames
- Device: CryoBalloon ablation
Primary outcomes (2)
- measure
- Safety of CryoBalloon Ablation in Treating Non-ampullary Non-polypoid Duodenal Adenomas (DAs) as Assessed by Participants With Adverse Events
- timeFrame
- 1 year
- description
- 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
- measure
- Participants With Complete Eradication of DA
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.