Disposable Endoscope Platform in Third Space Endoscopic Procedures (NCT06738628)
Pilot Prospective Trial to Demonstrate Efficacy, Feasibility, and Safety of a Disposable Endoscope Platform in Third Space Endoscopic Procedures
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Baylor College of Medicine — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
- (Esophageal or Gastric) Per-Oral Endoscopic Myotomy (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Baylor College of Medicine — Houston, Texas
📞 Contact the Study Coordinator
Phone: (713) 798-0950
Email: Mohamed.Othman@bcm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.