Clinical trial NCT01633411: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Barrett's esophagus with or without dysplasia

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.

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.

Primary outcomes:
measure: Esophageal Stricture
timeFrame: 6 to 8 Weeks
Secondary outcomes:
measure: Post-procedure pain relative
timeFrame: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
measure: Presence of Residual Barrett's Esophagus
timeFrame: 6 to 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: New York
country: United States
facility: Columbia Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Bas L Weusten, MD, pHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.