Disposable Endoscope Platform in Third Space Endoscopic Procedures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaylor College of Medicine
About this trial
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
Qualifiers
Patient is ≥ 18 years old.
Patients can provide informed consent.
Patient is referred for third space endoscopic procedure including e-POEM, g-POEM.
Disqualifiers
Patient is < 18 years old.
Patient refused and/or unable to provide consent.
Patient is a pregnant woman.
Trial design
Treatments tested in this trial
- (Esophageal or Gastric) Per-Oral Endoscopic Myotomy
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov