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Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554356
Recruitment Status : Suspended (Device modifications required prior to trial proceeding.)
First Posted : June 13, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
PENTAX of America, Inc.
Johns Hopkins University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Intestinal Metaplasia Esophageal Dysplasia Device: CryoBalloon Focal Ablation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Cryoballoon Focal Ablation System (CbFAS) Treatment
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.
Device: CryoBalloon Focal Ablation System
CryoBalloon Focal Ablation System




Primary Outcome Measures :
  1. Percentage of all treated Subjects with complete eradication of all intestinal metaplasia (CEIM) within 12 months of enrollment. [ Time Frame: 12 months ]
  2. Percentage of all treated subjects with complete eradication of dysplasia (CED) within 12 months of enrollment [ Time Frame: 12 months ]
    Stratified by prior type of ablation treatment and baseline grade (LGD or HGD) will also be reported.

  3. Incidence of CryoBalloon-related serious adverse events [ Time Frame: 12 months ]
    Relation of serious adverse events to CryoBalloon device will be assessed by the PI


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: At end of treatment period, up to 12 months ]
    The device worked as expected on every application, defined as proportion of all CbFAS that perform as intended.

  2. Procedure success rate [ Time Frame: At end of treatment period, up to 12 months ]
    All columnar tissue that was planned to be treated was treated.

  3. Progression rate [ Time Frame: At end of treatment period, up to 12 months ]
    Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date.

  4. Survival curve analysis - time to CEIM [ Time Frame: At end of treatment period, up to 12 months ]
    Time to complete eradication of intestinal metaplasia (CEIM). Survival curve analysis from first treatment.

  5. Survival curve analysis - time to progression [ Time Frame: At end of treatment period, up to 12 months ]
    Time to progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer at 12 months from enrollment date. Survival curve analysis from first treatment.

  6. Survival curve analysis - time to recurrence [ Time Frame: At end of treatment period, up to 12 months ]
    Time to recurrence. Survival curve analysis from first treatment.

  7. Risk factors associated with failure to respond to CryoBalloon ablation [ Time Frame: At end of treatment period, up to 12 months ]
    Risk factors associated with failure to respond to CryoBalloon ablation

  8. Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date. [ Time Frame: At end of treatment period, up to 12 months ]
    Median number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.

  9. Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date. [ Time Frame: At end of treatment period, up to 12 months ]
    Mean number of CryoBalloon ablation treatments required to achieve CED and CEIM by 12 months from enrollment date.

  10. Proportion of subjects requiring narcotic analgesic - Day 1 [ Time Frame: Day 1 ]
    Proportion of subjects requiring narcotic analgesic at day 1 post treatment.

  11. Proportion of subjects requiring narcotic analgesic - Day 7 [ Time Frame: Day 7 ]
    Proportion of subjects requiring narcotic analgesic at day 7 post treatment.

  12. Proportion of subjects requiring narcotic analgesic - Day 30 [ Time Frame: Day 30 ]
    Proportion of subjects requiring narcotic analgesic at day 30 post treatment.

  13. Median pain score - Day 1 [ Time Frame: Day 1 ]
    Median pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  14. Median pain score - Day 7 [ Time Frame: Day 7 ]
    Median pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  15. Median pain score - Day 30 [ Time Frame: Day 30 ]
    Median pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  16. Mean pain score - Day 1 [ Time Frame: Day 1 ]
    Mean pain score immediately post-procedure day 1 as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  17. Mean pain score - Day 7 [ Time Frame: Day 7 ]
    Mean pain score 7 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  18. Mean pain score - Day 30 [ Time Frame: Day 30 ]
    Mean pain score 30 days after treatment as assessed by self-reported pain scale (0-10) where 0 is no pain and 10 is worst pain imaginable. Higher scores indicate more severe pain.

  19. Proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium [ Time Frame: At end of treatment period, up to 12 months ]
    For those who do not achieve CEIM and CED at 12 months from enrollment date, proportion of Barrett's Esophagus surface area reverted to neosquamous epithelium based on physician report.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
  2. Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:

    2.1. History of at least 3 RFA treatments, with one of the following:

    • 2.1.1. Residual BE Prague C1 - C3 and/or
    • 2.1.2. Residual BE >=M1 - M8 and/or
    • 2.1.3. One or more islands of residual BE >1 cm in diameter
    • 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
  3. 18 or older years of age at time of consent.
  4. Provides written informed consent.
  5. Willing to undergo an alternative approved standard of care treatment for their condition.
  6. Willing and able to comply with study requirements for follow-up.
  7. No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.

Exclusion Criteria:

  1. Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0).
  2. Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
  3. Symptomatic, untreated esophageal strictures.
  4. Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or ImCA identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that:

    4.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).

    4.2. Patients with intramucosal cancer (ImCA) must be at low risk for recurrence, confirmed by EMR pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.

  5. EMR or ESD < 6 weeks prior to baseline treatment.
  6. Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
  7. Active reflux esophagitis grade B or higher assessed during screening/baseline EGD.
  8. Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
  9. Uncontrolled coagulopathy.
  10. Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per American Society for Gastrointestinal Endoscopy (ASGE) guidelines for a high risk endoscopy procedure.
  11. Active fungal esophagitis.
  12. Known portal hypertension, visible esophageal varices, or history of esophageal varices.
  13. General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
  14. Pregnant or planning to become pregnant during period of study participation.
  15. Patient refuses or is unable to provide written informed consent.
  16. Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554356


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Northwell Health
Lake Success, New York, United States, 11042
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
United States, Texas
UTHealth Science Center/Herman Memorial
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of North Carolina, Chapel Hill
PENTAX of America, Inc.
Johns Hopkins University
Investigators
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Principal Investigator: Nicholas J Shaheeen, MD, MPH UNC Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03554356    
Other Study ID Numbers: 18-0388
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Barrett Esophagus
Metaplasia
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes