To explore safety and performance of Epi Kit in Adult & Pregnant subjects in Indian Population.

A prospective, single arm, multi-centric, post market clinical follow-up of Epi Kit to explore safety and performance in Adult & Pregnant subjects in Indian Population.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/02/049722

Enrollment

100

Registered

2023-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Epi Kit (NG-16 & 18), Epi Cath / Epidural Catheter Passes through (NG-16 & 18).: Maximum use not more than 3 days. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
successful completion of procedure in target population.Timepoint: Maximum use not more than 3 days.	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Anoop Batra

Romsons Group Private Limited

cta2@romsons.com8006599926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026