To explore safety and performance of Epi Kit in Adult & Pregnant subjects in Indian Population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/02/049722
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Males and Females (including the Pregnant Females) of age 18 years and above subjects who are expected to require short term / continuous anesthesia and / or analgesia, through the epidural route.
2.Subject who can provide Informed Consent Form (Adult / Pregnant Female) in writing and medically in a position to undergo consenting and screening process.
3.In case of Pregnant Female, the pregnant female need to provide Informed Consent Form (Pregnant Female) duly signed by herself as well as her Partner.
4.Subject who is willing and able to comply with the requirement of the follow-up.
5.In case of Pregnant Female, the pregnant female and/ or her Partner who is willing and able to comply with the requirement of the follow-up.
1.Subject present with medical emergency, where treatment is more priority than the informed consent process.
2.Subject, who cannot provide informed consent form (Adult/ Pregnant Female) such as unconscious, mentally challenged patient, etc.
3.In case of Pregnant Female, the pregnant female or her partner cannot provide Informed Consent Form (Pregnant Female) for her, etc.
4.Any known allergy with any of the material of Epi Kit and its component(s).
5.Other conditions, which in the opinion of investigators make the patient unsuitable for enrolment or could, interfere with his / her participation and in completion of the protocol.
6.Participation in another research study involving an active investigation within 30 days prior to consent.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method