CryoSpray Ablation (TM) GI Patient Registry

NCT00747448 | Completed

• 1 other identifier: 17-00030
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

Conditions

Barrett's Esophagus; Esophageal Cancer

Keywords

Barrett's Esophagus; High Grade Dysplasia; Low Grade Dysplasia; Squamous Dysplasia; Esophageal Cancer; CryoSpray Ablation; Cryotherapy; Cryospray

Outcome Measures

Primary Outcomes (1)

• Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions.

  2 years post treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including: 1. Barrett's esophagus with or without dysplasia 2. Squamous dysplasia of the esophagus 3. Esophageal cancer, any stage, as evidenced by histology.

You may qualify if:

• The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:
• Barrett's esophagus with or without dysplasia
• Squamous dysplasia of the esophagus
• Esophageal cancer, any stage

You may not qualify if:

• Subjects with esophageal lesions whose pathology was not one of the above.
• Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (6)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Syosset Hospital

Lake Success, New York, 10042, United States

Location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (8)

• Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008.

  PMID: 16301023 BACKGROUND

• Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4.

  PMID: 10385730 BACKGROUND

• Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.

  PMID: 10734018 BACKGROUND

• Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54. doi: 10.1016/0016-5085(94)90123-6.

  PMID: 8076761 BACKGROUND

• Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

  PMID: 8995932 BACKGROUND

• Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.

  PMID: 14629105 BACKGROUND

• Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34. doi: 10.1186/1477-7819-5-34.

  PMID: 17367523 BACKGROUND

• Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.

  PMID: 10349923 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Study Officials

• Ann Murphy Legg, RN

  CSA Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: May 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)