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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01633411
First received: June 28, 2012
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

This is a feasibility study without a primary study hypothesis or statistical comparison.


Condition Intervention Phase
Barrett's Esophagus
Device: Focal Cryoballoon Ablation System - 6 seconds
Device: Focal Cryoballoon Ablation System - 8 seconds
Device: CryoBalloon Focal Ablation System - 10 seconds
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Further study details as provided by C2 Therapeutics, Inc.:

Primary Outcome Measures:
  • Esophageal Stricture [ Time Frame: 6 to 8 Weeks ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Post-procedure pain relative [ Time Frame: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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.


Enrollment: 39
Study Start Date: December 2011
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
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."
Cohort B
Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
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."
Cohort C
Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
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".

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Barrett's esophagus with or without dysplasia

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633411

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21205
United States, New York
Columbia Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
C2 Therapeutics, Inc.
Investigators
Principal Investigator: Bas L Weusten, MD, pHD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Publications:
Responsible Party: C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01633411     History of Changes
Other Study ID Numbers: CP-0003.A
Study First Received: June 28, 2012
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 05, 2015