Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by C2 Therapeutics, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01293448
First received: December 14, 2010
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.


Condition Intervention Phase
Barrett's Esophagus
Esophageal Cancer
Device: Cryoballoon Ablation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Treatment effect [ Time Frame: Within 30 days of ablation procedure ] [ Designated as safety issue: No ]
    The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.


Secondary Outcome Measures:
  • Post-ablation symptoms [ Time Frame: Within 7 days of ablation procedure ] [ Designated as safety issue: Yes ]
    A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.

  • Post procedure pain [ Time Frame: Within 7 days of ablation procedure ] [ Designated as safety issue: Yes ]
    The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort A
Subjects in Cohort A will receive 10 seconds of Cryoballoon Ablation to esophageal tissue for 10 seconds.
Device: Cryoballoon Ablation
Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)
Other Names:
  • CryoBalloon Ablation System
  • cryoablation
Active Comparator: Cohort B
Subjects in Cohort B will receive 10 seconds of Cryoballoon Ablation to esophageal tissue for 12 seconds.
Device: Cryoballoon Ablation
Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)
Other Names:
  • CryoBalloon Ablation System
  • cryoablation
Active Comparator: Cohort C
Subjects in Cohort C will receive 10 seconds of Cryoballoon Ablation to esophageal tissue for 14 seconds.
Device: Cryoballoon Ablation
Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)
Other Names:
  • CryoBalloon Ablation System
  • cryoablation

Detailed Description:

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
  • Patient is 18 to 80 years of age at the time of consent (inclusive).
  • Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
  • Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
  • Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
  • Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

  • Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
  • Patient refuses or is unable to provide written informed consent. - -
  • Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
  • Patient has esophageal narrowing limiting access to the intended site of ablation.
  • Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
  • Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
  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: NCT01293448

Locations
United States, California
University of Southern California Completed
Los Angeles, California, United States, 90033
United States, New York
University of Rochester Completed
Rochester, New York, United States, 14642
United States, Pennsylvania
University of Pittsburgh Completed
Pittsburgh, Pennsylvania, United States, 15232
Netherlands
AMC Recruiting
Amsterdam, AZ, Netherlands, 1105
Contact: Dirk Scholvinck, MD       d.w.scholvinck@amc.uva.nl   
Principal Investigator: Jacques Bergman, MD         
Sponsors and Collaborators
C2 Therapeutics, Inc.
Investigators
Principal Investigator: Jacques Bergman, MD AIDS Malignancy Clinical Trials Consortium
Principal Investigator: Steve DeMeester, MD University of Southern California
Principal Investigator: Blair Jobe, MD University of Pittsburgh
Principal Investigator: Jeffery Peters, MD University of Rochester
  More Information

No publications provided

Responsible Party: C2 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01293448     History of Changes
Other Study ID Numbers: CP-0001.A
Study First Received: December 14, 2010
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board
Netherlands: Independent Ethics Committee

Keywords provided by C2 Therapeutics, Inc.:
Esophagectomy
Barrett's Esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 30, 2014