Disposable Endoscope Platform in Third Space Endoscopic Procedures

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06738628
Status
Not Yet Recruiting

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Conditions

  • Achalasia
  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (Esophageal or Gastric) Per-Oral Endoscopic Myotomy — PROCEDURE
    Performing Per-Oral Endoscopic Myotomy for the treatment of either achalasia of the esophagus, or gastroparesis of the stomach.

Study Details

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.

Key Dates

Start date
May 30, 2026
Status verified
Aug 2025
Primary completion
Oct 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)

Primary Outcome Measure

Technical Success [ Time Frame: Day 1 (procedure day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Mohamed O. Othman, MD
713-798-0950
Fares Ayoub, MD
7137980950

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