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Disposable Endoscope Platform in Third Space Endoscopic Procedures

StatusWithdrawn
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Withdrawn before enrolling Sponsor's reason: The study was closed by the investigator prior to enrollment of any participants. The IRB has been notified and the study is closed. Primary completion pushed from Oct 31, 2026 to Sep 30, 2027 · Enrollment target: estimated 40 to confirmed 0 · Start date: May 30, 2026 to Dec 30, 2026 · 5 more Show 8 more changesShow less
    • Primary completion pushed from Oct 31, 2026 to Sep 30, 2027
    • Enrollment target: estimated 40 to confirmed 0
    • Start date: May 30, 2026 to Dec 30, 2026
    • Completion pushed from Mar 31, 2027 to Dec 31, 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description revised
    • Site contact updated
  2. Primary completion date: Jan 31, 2026 to Oct 31, 2026 Start date: Oct 30, 2025 to May 30, 2026 · Completion date: Mar 31, 2026 to Mar 31, 2027v4 Show 2 more changesShow less
    • Start date: Oct 30, 2025 to May 30, 2026
    • Completion date: Mar 31, 2026 to Mar 31, 2027
  3. Start date: Mar 31, 2025 to Oct 30, 2025 Primary completion date: Dec 31, 2025 to Jan 31, 2026v3 Show 1 more changeShow less
    • Primary completion date: Dec 31, 2025 to Jan 31, 2026
  4. Start date: Jan 31, 2025 to Mar 31, 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06738628
Lead Sponsor Baylor College of Medicine
Conditions Achalasia, Gastroparesis
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov