Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05384093 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 25, 2025 → Oct 25, 2026
See other at-risk trials from Foundation for Orthopaedic Research and Education

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 25, 2025 to Oct 25, 2026
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 25, 2026 to Oct 25, 2026
    • Site details revised
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Oct 25, 2024 to Oct 25, 2025
    • Enrollment target: 270 to 210
    • Study completion date: Jun 25, 2025 to Jun 25, 2026
    • Study description revised
    v4
  4. Primary completion date: Jun 25, 2024 to Oct 25, 2024v3
  5. Primary endpoints revised (18)v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
Trial Details
NCT Number NCT05384093
Lead Sponsor Foundation for Orthopaedic Research and Education
Collaborators: Ermi LLC
Conditions
(from sponsor)		 Adhesive Capsulitis of Shoulder
Related terms Bursitis
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov