CTRI/2023/11/060230
Recruiting
Phase 4
A prospective, single arm, Post Market Clinical Follow-up(PMCF) study to evaluate the Safety and Performance of Clavicle Plate System - NI
Auxein Medical Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
- Sponsor
- Auxein Medical Pvt Ltd
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Subjects are willing and able to give informed consent for participation as well as willing for study follow ups
- •2 Male and female subjects aged between 18 years to 75 years
- •3 Subjects with confirmed diagnosis as per the indications as mentioned in investigators brochure
Exclusion Criteria
- •1 Infection local or Systemic Acute or Chronic Inflammation to the operative site
- •2 Female subject who is pregnant or planning pregnancy during the course of the study
- •3 Subject having Soft tissue or material sensitivity
- •4 Subjects who are unwilling or incapable of following post operative care instructions
- •5 Subjects having diagnosed Sepsis
- •6 Subjects who are incarcerated or have pending incarceration
Outcomes
Primary Outcomes
Not specified
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