E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tratamiento local de fístulas traqueo-esofágicas. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluar la factibilidad y seguridad de las ASC para tratar fístulas traqueo-esofágicas. |
|
E.2.2 | Secondary objectives of the trial |
Obtener unos datos preliminares de la efectividad y coste del tratamiento propuesto. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ser mayor de 18 años. 2. Tener patología fistulosa traqueoesofágica inflamatoria. 3. Fístula accesible al abordaje endoscópico. 4. Firmar el consentimiento informado. |
|
E.4 | Principal exclusion criteria |
1. No cumplir algún criterio de inclusión. 2. Alergia a anestésicos locales o azul de metileno. 3. Extrema delgadez que desaconseje la liposucción. 4. Urgencia en el tratamiento. 5. Intolerancia o rechazo de prótesis. 6. Antecedentes de abuso de alcohol o de otras sustancias adictivas en los 6 meses anteriores a la inclusión. 7. Neoplasia maligna, salvo que se trate de carcinoma basocelular o epidermoide de la piel o antecedentes de tumores malignos, salvo que se hayan encontrado en fase de remisión durante los 5 años anteriores. 8. Enfermedad cardiopulmonar que, en opinión del investigador, resulte inestable o revista la gravedad suficiente para descartar al paciente del estudio. 9. Enfermedad médica o psiquiátrica de cualquier tipo que, en opinión del investigador, pueda suponer un motivo de exclusión del estudio. 10. Sujetos con inmunodeficiencias congénitas o adquiridas. Hepatitis B y/o C o tuberculosis diagnosticada en el momento de la inclusión, treponema. 11. Mujeres embarazadas o lactantes. 12. Administración de cualquier fármaco en investigación en el momento actual o tres meses antes del reclutamiento para este ensayo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Factibilidad y seguridad del estudio. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |