Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 29, 2025 → Nov 29, 2026
See other at-risk trials from MiWEndo Solutions S.L.

Record History

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  1. Primary and study completion pushed from Dec 29, 2025 to Nov 29, 2026
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 5 words
  2. Primary and study completion dates: Dec 29, 2024 to Dec 29, 2025v4
  3. Eligibility criteria shortened, about 38 words
    • Secondary endpoints: 7 to 4
    • Study description shortened, about 28 words
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 22, 2023 to Dec 29, 2024
    v2
  5. Study First Submitted
  • 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.
The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)
Trial Details
NCT Number NCT05988645
Lead Sponsor MiWEndo Solutions S.L.
Conditions
(from sponsor)		 Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Adenocarcinoma, Colorectal Neoplasms
Related terms Colorectal Neoplasms, Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov