Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

Phase 4

Completed

• Conditions: Barrett's Esophagus; Esophageal Cancer
• Interventions: Device: Cryo Spray Ablation

• Registration Number: NCT00754468
• Lead Sponsor: CSA Medical, Inc.

Brief Summary

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Detailed Description

The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date.

All subjects will receive narcotic analgesics to control symptoms.

Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.

Study Timeline

• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-18
• Study Start: 2009-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2014-06-09
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Results First Posted: 2015-11-04
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Age 18 years of age
• Esophagectomy planned based on clinical situation not related to this study.
• Deemed operable based on institutional criteria.

Exclusion Criteria

• Pregnant
• Esophageal stricture preventing passage of endoscope or catheter.
• 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.
• Refusal or inability to give consent.
• Concurrent chemotherapy.
• Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA 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.
• Prior radiation therapy which involved the esophagus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Cryo Spray Ablation	Cryo Spray Ablation	cryo spray ablation applied to healthy tissue 2 cycles x20 seconds
Group 1: Cryo Spray Ablation	Cryo Spray Ablation	cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds

Primary Outcome Measures

Name	Time	Method
Depth of Injury	End of Study	histopathological findings analyzed to determine max depth of injury (mm)

Secondary Outcome Measures

Name	Time	Method
Side Effects of Subjects Receiving Cryospray Therapy.	End of Study

Trial Locations

Locations (1)

University of Miami, Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States