Disposable Endoscope Platform in Third Space Endoscopic Procedures
Megadott ok: The study was closed by the investigator prior to enrollment of any participants. The IRB has been notified and the study is closed.
A legfontosabb adatok
- Hol
- Houston (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Baylor College of MedicineHouston, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Baylor College of Medicine
- Azonosító
- NCT06738628
- A regiszteradat frissítve
- 2026. október 1.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Pilot Prospective Trial to Demonstrate Efficacy, Feasibility, and Safety of a Disposable Endoscope Platform in Third Space Endoscopic Procedures
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.
Bevonási feltételek: Patient is ≥ 18 years old; Patients can provide informed consent; Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.
Kizáró feltételek: Patient is < 18 years old; Patient refused and/or unable to provide consent; Patient is a pregnant woman.