- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03776188
Endoscopic Suturing (ES) Registry
Prospective Registry for Trans-Orifice Endoscopic Suturing Applications
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.
To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.
To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.
To collect data on the common use endoscopic suturing therapy in other indications.
This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.
This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.
The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.
All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72211
- University of Arkansas
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic Jacksonville
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Jacksonville, Florida, Estados Unidos, 32256
- Borland Grover Clinic
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- NorthShore University HealthSystem
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Medical Institution
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University
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New York
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Manhasset, New York, Estados Unidos, 11030
- Northwell Health
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New York, New York, Estados Unidos, 10021
- New York Presbyterian Hospital
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New York, New York, Estados Unidos, 10029
- Mount Sinai Hospital
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Hershey Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75214
- Methodist Dallas Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Selected to undergo trans-orifice suturing prior to study enrollment
- Age 18+ years
- Patient ASA classification I, II, III, including emergency cases
- Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment
Exclusion Criteria:
- Patients who do not meet the clinical criteria for trans-orifice suturing
- Under age 18 years
- ASA classification IV
- Unable to provide informed consent
- Unable to participate in follow-up assessments
- Uncorrectable coagulopathy at the time of endoscopic suturing
- Any terminal disease that limits patient's survival to less than one year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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no groups - observational study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dislocation of Stent - distance
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
|
Change in the position measured using distance (centimeters).
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Change at 2 weeks, 30 days, 3 months
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Dislocation of Stent - location
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
|
Change in the position measured using location.
Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - placement
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
|
Distal from placement over time (yes or no)
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - replaced
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
|
Stent replaced or re-structured over time (yes or no)
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - sutures
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
|
Number of intact Sutures
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Change at 2 weeks, 30 days, 3 months
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Migration Rate of Stent - removal
Periodo de tiempo: Change at 2 weeks, 30 days, 3 months
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Days to removal and replacement
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Change at 2 weeks, 30 days, 3 months
|
Excess Weight Loss
Periodo de tiempo: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
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Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Total Weight Loss
Periodo de tiempo: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
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Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Maranki, MD, Penn State Milton S. Hershey School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ES Registry 2-682-101
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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