NCT01287312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 27, 2011

Last Update Submit

January 31, 2011

Conditions

Tracheo Esophageal Fistula

Keywords

We will treat children age 1 month to 20 years with recurrent TEF after surgical failure

Outcome Measures

Primary Outcomes (1)

  • Closure of the fistula

    Closure of the fistula

Secondary Outcomes (1)

  • clinical and pulmonary improvment

Interventions

Endoscopic repair of recurrent TEF by trichloroacetic acid aplicationsPROCEDURE

Eligibility Criteria

Age1 Month - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children age 1 month- 20 years old with recurrent TEF.
  • Failure of surgical repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Esophageal FistulaDigestive System FistulaDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract FistulaRespiratory Tract DiseasesTracheal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

shlomo cohen, MD

CONTACT

+972 2 6776817shlomoco@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 1, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

IL(1)