NCT00321958

Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.

Detailed description

Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal adenocarcinoma. Eliminating this condition may control the current rapid rise of adenocarcinoma. Ablative techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery. Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost, patient discomfort and/or significant complications. A novel device which sprays liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment. This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to confirm preliminary results in humans.

Conditions

• Barrett Esophagus
• Esophageal Neoplasms
• Deglutition Disorders
• GERD
• Neoplasm

Interventions

Type	Name	Description
DEVICE	CSA System (CryoSpray AblationTM System)	10 second spray times
DEVICE	CryoSpray Ablation	10 second spray times

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-05-04
• Last updated: 2022-02-08

Locations

1 site across 1 country: United States