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Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

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: NCT01633411
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.

Tracking Information
First Submitted Date June 28, 2012
First Posted Date July 4, 2012
Last Update Posted Date April 28, 2015
Study Start Date December 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2012)
Esophageal Stricture [ Time Frame: 6 to 8 Weeks ]
Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 29, 2012)
  • Post-procedure pain relative [ Time Frame: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day) ]
    A secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale (0 to 10). Patients is asked to score pain level in the treatment area and swallowing.
  • Presence of Residual Barrett's Esophagus [ Time Frame: 6 to 8 weeks ]
    Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include:
    1. detailed description of the presence of Barrett's Esophagus and/or squamous mucosa.
    2. estimate of percentage of residual Barrett's in each sample
    3. the detailed description of any residual injury at all levels within the sample.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Official Title Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Brief Summary This is a feasibility study without a primary study hypothesis or statistical comparison.
Detailed Description

The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.

Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.

Evaluations include, but are not limited to the following:

  • Deployment ease/scope compatibility.
  • Device malfunctions.
  • Time of catheter deployment.
  • Adverse events.
  • Stricture formation at 6 to 8 weeks.
  • Patient Pain.
  • Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Barrett's esophagus with or without dysplasia
Condition Barrett's Esophagus
Intervention
  • Device: Focal Cryoballoon Ablation System - 6 seconds
    Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
  • Device: Focal Cryoballoon Ablation System - 8 seconds
    Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
  • Device: CryoBalloon Focal Ablation System - 10 seconds
    Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications".
Study Groups/Cohorts
  • Cohort A
    Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
    Intervention: Device: Focal Cryoballoon Ablation System - 6 seconds
  • Cohort B
    Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
    Intervention: Device: Focal Cryoballoon Ablation System - 8 seconds
  • Cohort C
    Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
    Intervention: Device: CryoBalloon Focal Ablation System - 10 seconds
Publications * Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2015)
39
Original Estimated Enrollment
 (submitted: June 29, 2012)
35
Actual Study Completion Date June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
  2. Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
  3. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
  4. Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

  1. Patient with endoscopically active inflammation in the treatment zone
  2. Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
  3. Patient has a 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.
  4. Patient refuses or is unable to provide written informed consent.
  5. Patients that are pregnant.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01633411
Other Study ID Numbers CP-0003.A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party C2 Therapeutics, Inc.
Study Sponsor C2 Therapeutics, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Bas L Weusten, MD, pHD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account C2 Therapeutics, Inc.
Verification Date April 2015