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ACTIVE NOT RECRUITING
NCT03847636
NA

CryoBalloon Ablation for Treatment of Duodenal Adenomas

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Cryoballoon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas (the C2D2 Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2019-05-13

Completion Date

2026-03

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

DEVICE

CryoBalloon ablation

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

Locations (4)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Northwell Health

Manhasset, New York, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Methodist Dallas Medical Center

Dallas, Texas, United States