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Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

This study has been terminated.
(The sponsor determined that adequate data had been acquired.)
Sponsor:
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00321958
First received: May 3, 2006
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  Purpose

The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.


Condition Intervention Phase
Barrett Esophagus
Esophageal Neoplasms
Deglutition Disorders
GERD
Neoplasm
 Device: CSA System (CryoSpray AblationTM System)
Device: CryoSpray Ablation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • HGD or inoperable intramucosal or submucosal carcinoma ans severe squamous dysplasia: measure of reduction in size of HGD or carcinoma [ Time Frame: Study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma [ Time Frame: Study midpoint and end ] [ Designated as safety issue: No ]
  • Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Number of treatment sessions needed to ablate dysplasia [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CSA System (CryoSpray AblationTM System)
    10 second spray times
    Other Names:
    • CSA
    • Cryo
    Device: CryoSpray Ablation
    10 second spray times
    Other Names:
    • CSA
    • cryo
Detailed Description:

Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal adenocarcinoma. Eliminating this condition may control the current rapid rise of adenocarcinoma. Ablative techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery. Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost, patient discomfort and/or significant complications. A novel device which sprays liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment.

This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to confirm preliminary results in humans.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High Grade-IMCancer:

    • Diagnosis of Barrett's esophagus and high-grade dysplasia or intramucosal carcinoma
    • 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 discussion of the highly experimental nature of cryotherapy
    • CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement)
    • Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa
    • Pathology review of esophageal biopsies by two independent reviewers, including at least one from the Department of Pathology at the University of Maryland, to confirm the diagnosis of Barrett's esophagus with HGD and/or IMCA
    • Presentation and discussion at Thoracic Tumor Board

  • Mucosal/submucosal cancer:

    • Diagnosis of esophageal carcinoma
    • 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 discussion of the highly experimental nature of cryotherapy
    • CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension through the wall or lymph node involvement)
    • Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement and primary lesion extending into submucosa or muscularis propria (T1smN0 or T2N0)
    • Presentation and discussion at Thoracic Tumor Board
    • Patients who have undergone previous ablation therapies are eligible for this study.

  • Severe squamous dysplasia:

    • Diagnosis of severe dysplasia within esophageal squamous mucosa
    • 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 discussion of the highly experimental nature of cryotherapy
    • CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement)
    • Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa
    • Pathology review of esophageal biopsies by two independent reviewers, including at least one from the Department of Pathology at the University of Maryland, to confirm the diagnosis
    • Presentation and discussion at Thoracic Tumor Board

Exclusion Criteria:

  • Age less than 18 years
  • Co-morbid illness expected to cause death within 6 months
  • Pregnancy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321958

Locations
United States, Maryland
University of Maryland School of Medicine and Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1505
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Bruce D Greenwald, M.D. University of Maryland
  More Information

Additional Information:
Click here for more information about this study: Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer  This link exits the ClinicalTrials.gov site

Publications:
Johnston, M.H., Eastone, J.A., Horwhat, J.D., Cartledge, J., Mathews, J.S., & Foggy, J.R. Cryoablation of Barrett's esophagus (BE): A pilot study [Electronic version]. Gastrointestinal Endoscopy 62:842-848,2005.
Johnston, M.H., Eastone, J.A., & Horwhat, J.D. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98: (9,Suppl), A30,S11, 2003.

Responsible Party: Bruce Greenwald, MD Principle Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT00321958     History of Changes
Other Study ID Numbers: H-27406, CCT Number = 3511
Study First Received: May 3, 2006
Last Updated: January 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Barrett Esophagus
Esophageal Neoplasm
Deglutition disorders
Cryotherapy
Cryosurgery
 GERD
Neoplasm
Esophagus
Endoscopy, Digestive System

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Deglutition Disorders
Esophageal Diseases
Esophageal Neoplasms
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
 Gastrointestinal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Esophageal Motility Disorders

ClinicalTrials.gov processed this record on May 16, 2013