Trichloroacetic Acid for Endoscopic Tracho-esophageal Fis... | NCT01287312

Studies
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

NCT01287312

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Feb 1, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Tracheo Esophageal Fistula

Interventions

Endoscopic repair of recurrent TEF by trichloroacetic acid aplications

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Jan 27, 2011

First Submission Date that Met QC Criteria

Jan 31, 2011

First Posted Date

Feb 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2011

Last Update Posted Date

Feb 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic repair of recurrent TEF by trichloroacetic acid aplications	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Closure of the fistula	Closure of the fistula

Secondary Outcomes

Measure	Description	Time Frame
clinical and pulmonary improvment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shlomo cohen, MD	Contact	+972 2 6776817		shlomoco@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014138	Tracheoesophageal Fistula

Ancestor Terms

ID	Term
D004937	Esophageal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D004935	Esophageal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided