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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System (ColdPlayIII)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02514525
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
C2 Therapeutics, Inc.

Brief Summary:
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: CryoBalloon Ablation System Not Applicable

Detailed Description:
Coldplay III is a multi-center, prospective study that will provide evidence of the efficacy and safety of the System in treatment of patients with previously untreated (treatment naïve) low grade dysplasia (LGD) or high grade dysplasia (HGD) BE. Subjects may have a maximum of five (5) ablation treatment sessions during their 12 months of study participation to achieve complete eradication of their dysplastic BE and intestinal metaplasia. As many ablations as needed to treat the dysplastic areas are allowed in each treatment session at the discretion of the investigator.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
Study Start Date : March 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
CryoBalloon Ablation System
Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Device: CryoBalloon Ablation System
CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.
Other Name: CryoBalloon Focal Ablation System

Primary Outcome Measures :
  1. Incidence of serious, CryoBalloon Ablation System-related adverse events [ Time Frame: 12 months ]
  2. Percentage of patients with baseline LGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  3. percentage of patients with baseline HGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  4. percentage of all treated patients who have complete eradication of all dysplasia (CE-D) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM) [ Time Frame: 12 months ]
  2. Percentage of subjects with progression of dysplasia from LGD to HGD or esophageal cancer, or progression of HGD to cancer [ Time Frame: 12 months ]
    For Baseline LGD and HGD subjects: progression of dysplasia

  3. Incidence of all treatment-related and all serious, non-treatment-related adverse events [ Time Frame: 12 months ]
  4. Incidence of post procedure chest discomfort events / Pain score >0 and <5 [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)

  5. Incidence of post procedure chest discomfort events / Pain score ≥5 and requiring narcotic analgesic [ Time Frame: Day 7 ]
    (scored on a 0-10 visual analog pain scale)

  6. Mean and Median Pain score on Day 1 post procedure [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)

  7. Mean and Median Pain score on Day 7 post procedure [ Time Frame: Day 7 ]
    (scored on a 0-10 visual analog pain scale)

  8. Rate of (CE-D) and all esophageal (CE-IM) will be reported as a percentage of all subjects enrolled, and stratified by baseline dysplasia grade [ Time Frame: 24 and 36 months ]
  9. Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM [ Time Frame: 12 months ]
    (mean and median)

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

Inclusion Criteria:

  • Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
  • BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
  • Older than 18 years of age at time of consent
  • Operable per institution's standards
  • Provides written informed consent on the approved informed consent form
  • Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

  • Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
  • Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
  • Symptomatic untreated strictures
  • Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
  • History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
  • History of esophageal varices
  • Large (>4cm) hiatal hernia
  • Prior distal esophagectomy
  • Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
  • Active esophagitis grade B or higher
  • Severe medical comorbidities precluding endoscopy
  • Uncontrolled coagulopathy
  • Pregnant or planning to become pregnant during period of study participation
  • Patient refuses or is unable to provide written informed consent
  • Life expectancy ≤3 years, as judged by the site investigator
  • General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

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 identifier (NCT number): NCT02514525

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Contact: Marcia Wachna, RN 650-996-2183
Contact: Marcia Canto, MD 410-964-5199

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United States, California
UC Irvine Recruiting
Orange, California, United States, 92868
Contact: Eva Maurer    714-456-2215   
Principal Investigator: Kenneth Chang, MD         
United States, Florida
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Diane Barrett    941-365-6556   
Principal Investigator: F. Scott Corbett, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kianoush Donboli    773-926-8490   
Principal Investigator: Irving Waxman, MD         
United States, Maryland
John Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Hilary Cosby, RN    410-502-2893   
Principal Investigator: Mimi Canto, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele Johnson    507-293-5307 ext 3-5307   
Principal Investigator: Prasad G. Iyer, MD         
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Molly Stewart, BS    516-321-8017   
Principal Investigator: Arvind Trindad, MD         
New York Presbyterian Hospital-Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Robert Garofano    212-304-5686   
Principal Investigator: Julian Abrams, MD         
United States, North Carolina
University of North Carolina School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Yaa Ofori-Marfoh    919-843-5884   
Principal Investigator: Nicholas J. Shaheen, MD, MPH         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Wendy Brock, RN    216-844-3853   
Principal Investigator: Amitabh Chak, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Michelle Kopfinger, RN    570-214-5420   
Principal Investigator: David Diehl, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mike Matthews    215-503-2545   
Principal Investigator: Anthony Infantolino, MD         
Sponsors and Collaborators
C2 Therapeutics, Inc.
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Principal Investigator: Marcia Canto, MD Johns Hopkins Medical Center

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Responsible Party: C2 Therapeutics, Inc. Identifier: NCT02514525     History of Changes
Other Study ID Numbers: CP-0011
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases