Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

• ClinicalTrials.gov Identifier: NCT01293448
• Recruitment Status: Completed
• First Posted: February 10, 2011
• Last Update Posted: April 28, 2022
• Sponsor: Pentax Medical
• Information provided by (Responsible Party): Pentax Medical

Tracking Information

• First Submitted Date: December 14, 2010
• First Posted Date: February 10, 2011
• Last Update Posted Date: April 28, 2022
• Study Start Date: December 2010
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2011)

Treatment effect [ Time Frame: Within 30 days of ablation procedure ]

The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 9, 2011)

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

• 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 Balloon-based Cryoablation of Human Esophageal Epithelium
• Official Title: Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
• Brief Summary: The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Barrett's Esophagus
• Esophageal Cancer

Intervention

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

Study Arms

Experimental: Intervention

CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.

Intervention: Device: Cryoballoon Ablation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2015): 21
• Original Estimated Enrollment (submitted: February 9, 2011): 20
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility 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).

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

Administrative Information

• NCT Number: NCT01293448
• Other Study ID Numbers: CP-0001.A
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pentax Medical
• Original Responsible Party: Peter Garcia-Meza, C2 Therapeutics
• Current Study Sponsor: Pentax Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jacques Bergman, MD; AIDS Malignancy 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

• PRS Account: Pentax Medical
• Verification Date: January 2018