Tracheo Esophageal FistulaNCT01287312
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
A study testing Endoscopic repair of recurrent TEF by trichloroacetic acid aplications in people with Tracheo Esophageal Fistula, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Tracheo Esophageal Fistula
- What is being tested?
- Endoscopic repair of recurrent TEF by trichloroacetic acid aplications
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children age 1 month- 20 years old with recurrent TEF.
- Failure of surgical repair.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Hadas Lemberg, PhD, +972 2 6776095, lhadas@hadassah.org.il
Shlomo Cohen, DM
About this study
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.
Read the 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.
- Conditions
- Tracheo Esophageal Fistula
- Being tested
- Endoscopic repair of recurrent TEF by trichloroacetic acid aplications
- Keywords
- We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
- Medical subject headings
- Tracheoesophageal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic repair of recurrent TEF by trichloroacetic acid aplicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the fistula
Closure of the fistula
Secondary outcomes (1)
clinical and pulmonary improvment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheo Esophageal FistulaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287312
- Sponsor's protocol ID
- shlomoco-HMO-CTIL
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
- ClinicalTrials.gov ID
- NCT01287312
- Acronym / sponsor ID
- shlomoco-HMO-CTIL
- Conditions
- Tracheo Esophageal Fistula
- Keywords
- We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children age 1 month- 20 years old with recurrent TEF.
- Failure of surgical repair.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic repair of recurrent TEF by trichloroacetic acid aplications | Procedure or surgery | – |
Primary outcome
Closure of the fistula
Closure of the fistula
1 secondary outcome
clinical and pulmonary improvment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic repair of recurrent TEF by trichloroacetic acid aplications in people with Tracheo Esophageal Fistula, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shlomo cohen, MD (+972 2 6776817, shlomoco@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of the fistula. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011; AzTrials last refreshed its copy on 8 Nov 2026.