- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Arkansas
-
Little Rock, Arkansas, Spojené státy, 72211
- University of Arkansas
-
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Florida
-
Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic Jacksonville
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Jacksonville, Florida, Spojené státy, 32256
- Borland Grover Clinic
-
-
Illinois
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Evanston, Illinois, Spojené státy, 60201
- NorthShore University HealthSystem
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Maryland
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Baltimore, Maryland, Spojené státy, 21224
- Johns Hopkins Medical Institution
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-
Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University
-
-
New York
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Manhasset, New York, Spojené státy, 11030
- Northwell Health
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New York, New York, Spojené státy, 10021
- New York Presbyterian Hospital
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New York, New York, Spojené státy, 10029
- Mount Sinai Hospital
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Penn State Hershey Medical Center
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Texas
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Dallas, Texas, Spojené státy, 75214
- Methodist Dallas Medical Center
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
no groups - observational study
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Dislocation of Stent - distance
Časové okno: Change at 2 weeks, 30 days, 3 months
|
Change in the position measured using distance (centimeters).
|
Change at 2 weeks, 30 days, 3 months
|
Dislocation of Stent - location
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Change at 2 weeks, 30 days, 3 months
|
Number of intact Sutures
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - removal
Časové okno: Change at 2 weeks, 30 days, 3 months
|
Days to removal and replacement
|
Change at 2 weeks, 30 days, 3 months
|
Excess Weight Loss
Časové okno: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
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
|
Total Weight Loss
Časové okno: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
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.
|
Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jennifer Maranki, MD, Penn State Milton S. Hershey School of Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- ES Registry 2-682-101
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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