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NCT06738628
Disposable Endoscope Platform in Third Space Endoscopic Procedures
Conditions: Achalasia, Gastroparesis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Sponsor: Baylor College of Medicine
Location: Baylor College of Medicine Houston Texas
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06738628). StuddyBuddy aggregates publicly available trial information.