A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers - Tabular View

Tracking Information

First Received Date ^ICMJE

March 30, 2008

Last Updated Date

April 1, 2008

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the efficacy and safety of esophageal endoscopic cryospray ablation. [ Time Frame: Safety is evaluated with each treatment. Efficacy result evaulation assessed at the 20 pt. milestone and after 37 patients. Treatment time frame: baseline and every 6 weeks. Surveillance phase biopsies at :3 ,6,9,12,18.24 months. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00650988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the degree of tumor ablation of inoperable esophageal cancer(T1sm or T2N0) [ Time Frame: Visual assessment each visit. Quick look biopsies may be done. Treatment time frame: baseline and every 6 weeks. Surveillance phase: Biopsies at 3,6,9,12,18,24 months. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers

Official Title ^ICMJE

Brief Summary

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Barretts Esophagus
Esophageal Cancer

Intervention ^ICMJE

Procedure: Cryospray Ablation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2011

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Group 1:

Co-morbid conditions such as severe heart, lung, kidney or liver disease.
Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.

Group 2:

Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall (T1sm or T2N0)

Exclusion Criteria:

Age less than 18 years
Co-morbid illness expected to cause death within 6 months
Pregnancy
Refusal or inability to give consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00650988

Responsible Party

John A. Dumot D.O. , Vice Chairman of Clinical Practice, The Cleveland Clinic

Study ID Numbers ^ICMJE

IRB 8270, Cleveland Clinic IRB 8270

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John A. Dumot, D.O.

Cleveland Clinic

Information Provided By

The Cleveland Clinic

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP