Barrett's EsophagusNCT00747448
CryoSpray Ablation (TM) GI Patient Registry
An observational study of Barrett's Esophagus and Esophageal Cancer, run by CSA Medical, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Esophageal Cancer
- How many people
- 199 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Scripps Research Institute
La Jolla, California, 92037
Syosset Hospital
Lake Success, New York, 10042
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Keywords
- Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia, Squamous Dysplasia, Esophageal Cancer, CryoSpray Ablation, Cryotherapy, Cryospray
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startMay 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Murphy Legg, RN, Study director, CSA Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747448
- Sponsor's protocol ID
- 17-00030
- Status last verified
- Feb 2016
- First submitted
- 4 Sep 2008
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16301023Johnston 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.
PubMed 10385730Ell 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.
PubMed 10734018Champion 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.
PubMed 8076761Eisen 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.
PubMed 8995932Johnston 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.
PubMed 14629105Cash 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.
PubMed 17367523Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
PubMed 10349923
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CryoSpray Ablation (TM) GI Patient Registry
- ClinicalTrials.gov ID
- NCT00747448
- Acronym / sponsor ID
- 17-00030
- Conditions
- Barrett's Esophagus, Esophageal Cancer
- Keywords
- Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia, Squamous Dysplasia, Esophageal Cancer, CryoSpray Ablation, Cryotherapy, Cryospray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- CSA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 2 years post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 16301023Johnston 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.
- Background: PubMed 10385730Johnston 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.
- Background: PubMed 10734018Ell 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.
- Background: PubMed 8076761Champion 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.
- Background: PubMed 8995932Eisen 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.
- Background: PubMed 14629105Johnston 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.
- Background: PubMed 17367523Cash 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.
- Background: PubMed 10349923Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Murphy Legg, RN study director
CSA Medical, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Esophageal Cancer, run by CSA Medical, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747448, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.