Post Market Clinical Follow Up study is to confirm clinical performance and safety throughout the expected lifetime of the Surgical Gloves.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/05/042748
- Lead Sponsor
- PRIMUS GLOVES PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects must be which is prescribed by a medical practitioner. The inclusion criteria for the subjects for this study are as follows:
-Informed consent from the PI on behalf of all the subjects
-Subjects in which Surgical Gloves is used during surgical procedures.
Exclusion Criteria
The below Subjects are excluded from the study:
-Subjects without informed consent
-Subject who are sensitive to natural latex rubber
-Subject who are sensitive to synthetic latex(for nitrile gloves only)
-Subject who are sensitive to powder content in Surgical Gloves Powdered.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to confirm clinical performance and safety throughout the expected lifetime of the Surgical Gloves, the acceptability and to assess the Safety and Performance of our Medical devices with a post market clinical study. The primary objective is also measuring if the product had met its intended use as claimed by the Primus Gloves Private Limited.Timepoint: The duration of the study is 2 to 3 months.
- Secondary Outcome Measures
Name Time Method The Secondary Objective is to determine any undesirable events under normal condition of use and assess whether the risks outweigh the intended benefits of the device. This study will identify and analyze new emergent risks, known and unknown residual risks and contraindications identified and be formulated to address if any specific questions relating to the clinical safety or clinical performance of the device. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: The duration of the study is 2 to 3 months