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A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Barrett's Esophagus, Esophageal Cancer

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Trial Information

A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary effectiveness endpoints are the treatment effect and depth of injury in healthy tissue using endoscopic cryospray therapy in esophagectomy subjects.

Outcome Time Frame:

End of Study

Safety Issue:

No

Principal Investigator

Afonso Ribeiro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

16-00017

NCT ID:

NCT00754468

Start Date:

February 2009

Completion Date:

December 2012

Related Keywords:

  • Barrett's Esophagus
  • Esophageal Cancer
  • Barrett's Esophagus
  • Esophageal Cancer
  • Esophageal Dysplasia
  • Low Grade Dysplasia
  • High Grade Dysplasia
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of Miami, Sylvester Comprehensive Cancer CenterMiami, Florida  33136