CryoSpray Ablation (TM) GI Patient Registry

NCT ID: NCT00747448

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Barrett's Esophagus Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CSA Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann Murphy Legg, RN

Role: STUDY_DIRECTOR

CSA Medical, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Scripps Research Institute

La Jolla, California, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Syosset Hospital

Lake Success, New York, United States

Site Status

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16301023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10385730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10734018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8076761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8995932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14629105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17367523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10349923 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-00030

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.