Clinical trial NCT00747448: CryoSpray Ablation (TM) GI Patient Registry
Official title: CryoSpray Ablation (TM) GI Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Esophageal Cancer
Keywords: Barrett's Esophagus
High Grade Dysplasia
Low Grade Dysplasia
Squamous Dysplasia
Esophageal Cancer
CryoSpray Ablation
Cryotherapy
Cryospray
Lead sponsor: CSA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
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.

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.

Detailed description: The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: The Scripps Research Institute
state: California
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Lake Success
country: United States
facility: Syosset Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: CSA Medical, Inc.
name: Ann Murphy Legg, RN
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.