Acquired Tracheo-esophageal FistulaPhase 4TEFGoreHelexNCT01153061
Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
A Phase 4 study testing Fistula closure with Gore Helex Septal Occluder and Gore Helex Septal Occluder in people with Acquired Tracheo-esophageal Fistula, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acquired Tracheo-esophageal Fistula
- What is being tested?
- Fistula closure with Gore Helex Septal Occluder and Gore Helex Septal Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Dec 2012
- Phase
- Phase 4
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 14 years old
- Benign tracheoesophageal fistulas identified through bronchoscopy;
Who cannot join
- Malign neoplasia
- Current mechanical ventilation
- Immunosuppressed
- Current local inflammatory process at fistulas borders
- Other clinical risk factors
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
São Paulo, São Paulo, 05403-900
About this study
Official title: Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.
- Conditions
- Acquired Tracheo-esophageal Fistula
- Being tested
- Fistula closure with Gore Helex Septal Occluder, Gore Helex Septal Occluder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistula closure with Gore Helex Septal OccluderDevice
The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
Gore Helex Septal OccluderDevice
Fistula closure with endoscopic release of occluder in the fistula traject.
| Study group | Role | What they receive |
|---|---|---|
| Fistula closure with occluder | Experimental | Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder. Receives: Device: Fistula closure with Gore Helex Septal Occluder; Device: Gore Helex Septal Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder.
A thorax CT scan will ascertain correct positioning and stability of the occluder.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionDec 2012
Why it stopped: The study was terminated because the rate of prothesis dislocation was too high.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Tracheo-esophageal FistulaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, W.L.Gore & Associates
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Miguel L Tedde, MD, PhD, Principal investigator, Heart Institute (InCor)-HC of the Sao Paulo University Medica School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153061
- Sponsor's protocol ID
- USP-0201/10-TEF
- Acronym
- TEFGoreHelex
- Status last verified
- Mar 2013
- First submitted
- 8 Jun 2010
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
- ClinicalTrials.gov ID
- NCT01153061
- Acronym / sponsor ID
- TEFGoreHelex / USP-0201/10-TEF
- Conditions
- Acquired Tracheo-esophageal Fistula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because the rate of prothesis dislocation was too high.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute, W.L.Gore & Associates
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jun 2010 (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.
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fistula closure with occluder | Experimental | Device: Fistula closure with Gore Helex Septal Occluder, Device: Gore Helex Septal OccluderPatients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 14 years old
- Benign tracheoesophageal fistulas identified through bronchoscopy;
Key exclusion criteria (5 listed)
- Malign neoplasia
- Current mechanical ventilation
- Immunosuppressed
- Current local inflammatory process at fistulas borders
- Other clinical risk factors
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 |
|---|---|---|
| Fistula closure with Gore Helex Septal OccluderThe occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures | Device | Fistula closure with occluder |
| Gore Helex Septal OccluderFistula closure with endoscopic release of occluder in the fistula traject. | Device | Fistula closure with occluder |
Primary outcome
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
Time frame: 6 months
The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder. A thorax CT scan will ascertain correct positioning and stability of the occluder.
Results and safety
The study was stopped early (reason given: The study was terminated because the rate of prothesis dislocation was too high.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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.
Miguel L Tedde, MD, PhD principal investigator
Heart Institute (InCor)-HC of the Sao Paulo University Medica School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fistula closure with Gore Helex Septal Occluder and Gore Helex Septal Occluder in people with Acquired Tracheo-esophageal Fistula, run by University of Sao Paulo at 1 site in Brazil.
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 5 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: stopped early, as of the sponsor's last update on 19 Mar 2013. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated because the rate of prothesis dislocation was too high.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder (time frame: 6 months). 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 19 Mar 2013.