Pilot Prospective Trial to Demonstrate Efficacy, Feasibility, and Safety of a Disposable Endoscope Platform in Third Space Endoscopic Procedures
Baylor College of Medicine
Summary
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.
Description
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 endo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is ≥ 18 years old. 2. Patients can provide informed consent. 3. Patient is referred for third space endoscopic procedure including e-POEM, g-POEM. Exclusion Criteria: 1. Patient is \< 18 years old. 2. Patient refused and/or unable to provide consent. 3. Patient is a pregnant woman.
Interventions
- Procedure(Esophageal or Gastric) Per-Oral Endoscopic Myotomy
Performing Per-Oral Endoscopic Myotomy for the treatment of either achalasia of the esophagus, or gastroparesis of the stomach.
Location
- Baylor College of MedicineHouston, Texas