Back to resultsTrichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Primary Purpose
Tracheo Esophageal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Endoscopic repair of recurrent TEF by trichloroacetic acid aplications
Sponsored by
About this trial
This is an interventional treatment trial for Tracheo Esophageal Fistula focused on measuring We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
Eligibility Criteria
Inclusion Criteria:
- children age 1 month- 20 years old with recurrent TEF.
- Failure of surgical repair.
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Outcomes
Primary Outcome Measures
Closure of the fistula
Closure of the fistula
Secondary Outcome Measures
clinical and pulmonary improvment
Full Information
NCT ID
NCT01287312
First Posted
January 27, 2011
Last Updated
January 31, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01287312
Brief Title
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Official Title
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.
The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.
Detailed Description
Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.
We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheo Esophageal Fistula
Keywords
We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Endoscopic repair of recurrent TEF by trichloroacetic acid aplications
Primary Outcome Measure Information:
Title
Closure of the fistula
Description
Closure of the fistula
Secondary Outcome Measure Information:
Title
clinical and pulmonary improvment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children age 1 month- 20 years old with recurrent TEF.
Failure of surgical repair.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shlomo cohen, MD
Phone
+972 2 6776817
Email
shlomoco@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
+972 2 6776095
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Shlomo Cohen, DM
12. IPD Sharing Statement
Learn more about this trial
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
We'll reach out to this number within 24 hrs