Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus. - NCT00754468-33136(Clinical Trial 242324)
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Miami |
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State:
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FL |
| Zip Code: |
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33136 |
| Conditions: |
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Barrett's Esophagus - Esophageal Cancer |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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University of Miami, Sylvester Comprehensive Cancer Center
Miami, FL 33136
United States
Primary Contact:
Afonso Ribeiro, M.D.
Phone: 305-243-1000
Secondary Contact:
Tania Zamora
Email: tzamora@med.miami.edu
Phone: 305-243-3813 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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