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A Feedback-enabled Magnetic Device for Temporary Management of Blepharoptosis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from E-DA Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 31, 2026 to May 31, 2028
    • Secondary endpoints: details revised at 1 of 2 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Trial status: Active, Not Recruiting to Recruitingv6 Show 11 more changesShow less
    • Enrollment target: 16 to 40
    • Primary completion date: Sep 30, 2024 to Dec 31, 2026
    • Primary endpoints: 4 to 3
    • Study sites: 1 to 2
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Interventions: Magnetic device (Device) to Feedback-enabled magnetic device (Device)
    • Secondary endpoints expanded, about 36 words
    • Study description expanded, about 29 words
    • Collaborators: 2 to 4
    • Study title revised
    • Eligibility criteria shortened, about 4 words
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 31, 2024 to Sep 30, 2024
    • Site details revised
    v5
  4. Trial status: Suspended to Recruitingv4 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2022 to Apr 1, 2023
    • Primary completion date: Apr 1, 2024 to May 31, 2024
    • Site details revised
    • Collaborators expanded, about 11 words
  5. Trial status: Recruiting to Suspended Sponsor's reason: The device prototype was broken and fixed in 2020. The new simplified and miniaturized device will be finished and used on April 1, 2022.v3 Show 6 more changesShow less
    • Primary completion date: Jan 31, 2020 to Apr 1, 2024
    • Start date: Oct 14, 2018 to Apr 1, 2022
    • Study completion date: Oct 11, 2020 to Dec 31, 2024
    • Interventions: Magnetic device prototype (Device) to Magnetic device (Device)
    • Site details revised
    • Study title shortened, about 1 word
  6. Primary endpoints revised (4)v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
E-DA Hospital
7 trials monitored
See 1 trial at risk
To develop a feedback-enabled magnetic device for management of blepharoptosis and evaluate its efficacy and safety, including the gain of palpebral fissure height, visual field obstruction, blurred vision, foreign body sensation over the cornea, burning or hot sensation over facial skin, and erythema or pruritus over the eyelid, by performing a human trial on patients with blepharoptosis.
Trial Details
NCT Number NCT03812016
Lead Sponsor E-DA Hospital
Collaborators: National Yang Ming Chiao Tung University, The Industrial Technology Research Institute, Shin Kong Wu Ho-Su Memorial Hospital, National Science and Technology Council, Taiwan
Conditions
(from sponsor)		 Blepharoptosis, Device Usability
Related terms Blepharoptosis, Oculomotor Nerve Diseases
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov