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

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ClinicalTrials.gov Identifier: NCT02514525
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 3, 2015
Last Update Posted Date September 14, 2018
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Incidence of serious, CryoBalloon Ablation System-related adverse events [ Time Frame: 12 months ]
  • Percentage of patients with baseline LGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  • percentage of patients with baseline HGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  • percentage of all treated patients who have complete eradication of all dysplasia (CE-D) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Incidence of serious, CryoBalloon Ablation System-related adverse events [ Time Frame: 12 months ]
  • Percentage of patients with baseline LGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  • percentage of patients with baseline HGD who have complete eradication of all dysplasia [ Time Frame: 12 months ]
  • percentage of all treated patients who have complete eradication of all dysplasia (CR-dysplasia) [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT02514525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Percentage of subjects with complete eradication of all esophageal intestinal metaplasia (CE-IM) [ Time Frame: 12 months ]
  • 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
  • Incidence of all treatment-related and all serious, non-treatment-related adverse events [ Time Frame: 12 months ]
  • 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)
  • 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)
  • Mean and Median Pain score on Day 1 post procedure [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)
  • Mean and Median Pain score on Day 7 post procedure [ Time Frame: Day 7 ]
    (scored on a 0-10 visual analog pain scale)
  • 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 ]
  • Number of CryoBalloon ablation treatments required to achieve CE-D or CE-IM [ Time Frame: 12 months ]
    (mean and median)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Percentage of subjects with complete eradication of all esophageal intestinal metaplasia [ Time Frame: 12 months ]
  • 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 subjects: progression of dysplasia
  • 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 HGD subjects: progression of dysplasia
  • Incidence of all treatment-related and all serious, non-treatment-related adverse events [ Time Frame: 12 months ]
  • Incidence of post procedure chest discomfort events / Pain score >0 [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)
  • Incidence of post procedure chest discomfort events / Pain score >5, and requiring narcotic analgesic [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)
  • Median Pain score on Day 1 post procedure [ Time Frame: Day 1 ]
    (scored on a 0-10 visual analog pain scale)
  • Median Pain score on Day 7 post procedure [ Time Frame: Day 7 ]
    (scored on a 0-10 visual analog pain scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
Official Title  ICMJE Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Barrett Esophagus
Intervention  ICMJE 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
Study Arms  ICMJE CryoBalloon Ablation System
Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
Intervention: Device: CryoBalloon Ablation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
150
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
60
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marcia Wachna, RN 650-996-2183 marcia@c2therapeutics.com
Contact: Marcia Canto, MD 410-964-5199 mcanto@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514525
Other Study ID Numbers  ICMJE CP-0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Responsible Party C2 Therapeutics, Inc.
Study Sponsor  ICMJE C2 Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcia Canto, MD Johns Hopkins Medical Center
PRS Account C2 Therapeutics, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP