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CryoBalloon Ablation for Treatment of Duodenal Adenomas

NCT03847636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-05

Study results available
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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 (flat) duodenal adenomas.

Conditions

Interventions

DEVICE

CryoBalloon ablation

Endoscopic cryoablation (cryogen is nitrous oxide) using a CryoBalloon catheter to ablate up to 4 separate DAs.

Sponsors & Collaborators

Principal Investigators

  • Marcia I. Canto, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2025-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847636 on ClinicalTrials.gov