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NCT02230410 Clinical Trial

Cryo Balloon for Residual Barrett's Esophagus

Barrett's Esophagus Clinical Trial

— Cryoballoon  

Official title:
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02230410
Other study ID # 14-004771
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date May 26, 2017

Study information
Verified date January 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date May 26, 2017
Est. primary completion date May 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Age > 18 years old - Able to provide informed consent - Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection, Exclusion criteria: - Age younger than 18 years old - Presence of esophageal varices - Esophageal stricture precluding passage of an endoscope - Inability to provide informed consent - Esophageal cancer (T2 and above) - Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000 - Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CryoBalloon Focal Ablation

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Pentax Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Eradication of Barrett's Esophagus Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation 3 months post Cryoballon Focal Ablation
See also
  Status Clinical Trial Phase
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Recruiting NCT02018367 - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma Phase 2
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT01976351 - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus N/A
Terminated NCT00526786 - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus Phase 4
Completed NCT01401699 - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction N/A
Completed NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy N/A
Suspended NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus
Completed NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus N/A
Completed NCT02879721 - Expression and Function of the Renin-Angiotensin System in the Esophagus Phase 0
Completed NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus N/A
Completed NCT01439594 - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation N/A
Completed NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus N/A
Completed NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed NCT00588575 - Ramanspectroscopy in Barrett's Esophagus
Recruiting NCT00288119 - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition N/A
Completed NCT03813381 - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO). N/A
Completed NCT01961778 - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma N/A
Not yet recruiting NCT02033070 - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System N/A

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