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TerminatedNCT00526786ICEUpdated Mar 14, 2014

Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

A Phase 4 interventional study of CryoSpray Ablation System (510(k) NO: K070893) in Barrett's Esophagus, High Grade Dysplasia and Low Grade Dysplasia, sponsored by CSA Medical, Inc.. Terminated at 16 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-14.

Sponsored by CSA Medical, Inc. · Phase 4, Interventional, and Treatment

Why this study was terminated
Business Reasons
Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Read the detailed description

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

02

Conditions studied

  • Barrett's Esophagus
  • High Grade Dysplasia
  • Low Grade Dysplasia

Keywords

  • Low Grade Dysplasia
  • High Grade Dysplasia
  • Barrett's Esophagus
  • Cryospray ablation
  • ICE
  • Cryotherapy
  • Cryo
  • CryoSpray
03

In context

Barrett Esophagus

310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.

This study's enrollment of 78 is above the median of 62 across 186 interventional studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

CSA Medical, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Karnofsky performance status of 50-100%
  • Life expectancy greater than 5 years
  • Hematopoietic, Hepatic and Renal lab clearance
  • Previous endoscopy with histological confirmation of LGD or HGD within BE
  • For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery.
  • For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS).

Exclusion criteria

Exclusion Criteria:

  • Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years).
  • Esophageal stricture preventing passage of endoscope or catheter.
  • Active esophagitis
  • EMR performed less than 8 weeks prior to CSA treatment.
  • EMR performed on greater than 90% circumference of any area of the esophagus.
  • Any previous esophageal surgery, except fundoplication without complications.
  • Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
  • Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints.
  • Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol.
  • Medically unfit or other contraindication to tolerate upper endoscopy.
  • Inability to tolerate therapy with a proton pump inhibitor (PPI).
  • Refusal or inability to give consent.
  • Other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free).
  • Concurrent chemotherapy.
  • Prior radiation therapy which involved the esophagus.
  • Prior adenocarcinoma involving the esophagus or stomach.
  • Prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (actual)

Interventions

  • DeviceCryoSpray Ablation System (510(k) NO: K070893)

    no drug interventions specified

    Also known as: 510(k) NO: K070893

06

What researchers measure

Primary outcomes

  1. The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.

    Time frame: 2 years post treatment

Secondary outcomes

  1. 1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.

    Time frame: 2 years post treatment

07

Study locations

16 sites
  • University of California -Irvine
    Orange, California 92868, United States
  • Norwalk Hospital
    Norwalk, Connecticut 06856, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Hoboken Universtiy Medical Center
    Hoboken, New Jersey 07030, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Universtiy of North Carloina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Duke University Medical Center
    Durham, North Carolina 27708, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Lancaster Reginal Medical Center
    Lancaster, Pennsylvania 17604, United States
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Baylor University
    Dallas, Texas 75246, United States
08

References and documents

Publications

  • 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. PubMed 8076761 ↗
  • 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. PubMed 8995932 ↗
  • 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. PubMed 10734018 ↗
  • 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. PubMed 10385730 ↗
  • 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. PubMed 14629105 ↗
  • 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 16301023 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00526786
Lead sponsor
CSA Medical, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2007
Start date
Sep 2007
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Mar 14, 2014

Study contacts

Bruce Greenwald, M.D.
principal investigator · University of Maryland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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