Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Completed

Conditions: esophageal cancer
esophageal neoplasm
10017990
10017991
10017998

Registration Number: NL-OMON36325

Lead Sponsor: C2 Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

a) 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
b) Patient is 18 to 80 years of age at the time of consent (inclusive).
c) Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution*s reviewing IRB/EC.
d) Patient is willing and able to comply with study requirements.
e) Patient*s esophagectomy is clinically necessary due to reasons unrelated to this study.
f) Patient is deemed operable per standard institutional criteria.

Exclusion Criteria

a) 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.
b) Patient refuses or is unable to provide written informed consent.
c) 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.
d) Patient has esophageal narrowing limiting access to the intended site of ablation.
e) Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
f) 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Histological aspect of tissue after balloon based cryoabalation:<br /><br>(1) the percentage of mucosa ablated (Ablation is defined as any sign of<br /><br>irreversible injury (necrosis)).<br /><br>(2) the anatomic depth of injury.<br /><br>(3) a detailed description of the type of injury at each depth of the<br /><br>esophageal wall. </p><br>

Secondary Outcome Measures