Jednorazowa platforma endoskopowa w procedurach endoskopowych trzeciej przestrzeni
Pilotażowa, potencjalna próba wykazania skuteczności, wykonalności i bezpieczeństwa jednorazowej platformy endoskopowej w procedurach endoskopowych w trzeciej przestrzeni
This is a prospective, single-arm unblinded study performed at a single tertiary center in the United States. All subjects will receive standard medical care and no experimental interventions are going to be performed. The procedures will be performed by Dr. Mohamed Othman, Dr. Salmaan Jawaid, Dr. Tara Keihanian, and Dr. Fares Ayoub. All patients undergoing third space endoscopic procedures including e-POEM and g-POEM, meeting study inclusion criteria will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approached individually for further discussion about the study and obtaining informed consent.
The goal of this prospective, pilot trial is to demonstrate the efficacy, feasibility, safety, and clinical outcomes of third space endoscopic procedures completed using a disposable endoscope platform.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Over the past decade, therapeutic endoscopy has rapidly progressed giving rise to the fields of third space endoscopy and endoscopic surgery. In the foregut, esophageal per-oral endoscopic myotomy (e-POEM) has become the standard approach for achalasia with level I data supporting its use1. For gastroparesis, randomized clinical trial data 2 now supports gastric POEM (g-POEM) use for refractory cases with promising results particularly in diabetic and post-surgical patients.
Despite the remarkable advances in endoscopic therapy, there has been comparably slower progress in innovation for endoscopic platforms. In fact, current endoscope design is not significantly different from the earliest endoscopes where tip deflection is primarily controlled by rotating dials on the shaft of the endoscope and insufflation and suction are controlled by manual pressure-controlled buttons. Original fiberoptic gastroscopes were designed to facilitate diagnostic use, where the endoscopist manipulates tip-deflection dials using both hands while viewing the intestinal mucosa through a viewer, with an assistant moving the shaft of the endoscope. This same design was then adapted for colonoscopy, and later for duodenoscopy and endoscopic ultrasound. Despite significant progress in image quality, the endoscope remains a heavy device, requiring significant dexterity and musculoskeletal fitness on behalf of the endoscopist to perform endoscopy ergonomically without risking muscle injury. In addition, endoscopes require several supportive devices to function, including a separate water pump, video processor, computer screen and if needed an electrosurgical generator, making the portability of traditional endoscopic platforms quite limited.
More recently, rising concerns about infectious complications from reusable endoscopes have led to the development of several single-use endoscope platforms. A novel disposable endoscope (AMBU single-use disposable gastroscope; AMBU USA, Columbia, Md, USA) was recently approved by the U.S. Food & Drug Administration (FDA) in 2022 for use in humans. This endoscopic platform is designed for single use and comes with several advantages compared to traditional reusable endoscopes. The platform is significantly lighter, with a weight of 650 grams compared to a traditional reusable upper endoscope which weighs approximately 3900 grams. Additionally, the single use platform has a wider depth of field and significantly smaller video processor and built in portable screen. These advantages have led our group to use the endoscope for therapeutic foregut procedures including e-POEM and g-POEM with positive results. The investigators at Baylor College of Medicine most recently published a proof-of-concept experience 3 in using the disposable gastroscope for a case of e-POEM, where the significantly lighter weight of the endoscope allowed easier maneuverability and subjectively lower musculoskeletal strain for the performing endoscopist, with no negative effects on image quality or technical aspects of the procedure.
Before wider adoption, these perceived benefits need to be demonstrated in a larger, prospective trial confirming non-inferiority to historical data from reusable platforms and safety.
Typ studiów
Typ studiów
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Texas
-
Houston, Texas, Stany Zjednoczone, 77030
- Baylor College of Medicine
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
All patients 18 years or older, not pregnant (if a woman), consenting to the study, and presents for an Esophageal POEM, or Gastric POEM will be invited to participate on this study.
Opis
Inclusion Criteria:
- Patient is ≥ 18 years old.
- Patients can provide informed consent.
- Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.
Exclusion Criteria:
- Patient is < 18 years old.
- Patient refused and/or unable to provide consent.
- Patient is a pregnant woman.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: CASE_ONLY
- Perspektywy czasowe: PROSPECTIVE
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Technical Success
Ramy czasowe: Day 1 (procedure day)
|
Defined as the ability to perform entire myotomy (procedure) with the disposable endoscope. |
Day 1 (procedure day)
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total Procedure Time
Ramy czasowe: During Procedure
|
Total recorded time to perform procedure using disposable endoscope |
During Procedure
|
|
Intraprocedural adverse events
Ramy czasowe: During Procedure
|
Adverse events emerging during procedure |
During Procedure
|
|
Satisfactory scores on Endoscopist satisfaction
Ramy czasowe: Immediately following completion of the procedure
|
Satisfactory survey: with endoscope maneuverability (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree"), with endoscope functionality [insufflation, suction, accessory passage] (1-5 Likert scale), with endoscope image quality (1-5 Likert scale; 1 being "strongly disagree" to 5 being "strongly agree"). |
Immediately following completion of the procedure
|
|
Scores on musculoskeletal strain survey
Ramy czasowe: Immediately following completion of the procedure
|
Musculoskeletal Strain survey: Focused on Overall strain, wrist strain, shoulders strain, and neck strain |
Immediately following completion of the procedure
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Mohamed Othman, MD, Baylor College of Medicine
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- H-55176
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
There are no plans to share IPD to other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .