Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Romo Seal Adult- GS-5020, Romo Seal Midi- GS-5031, Romo Seal Kid- GS-5032.: Device maximum use duration is not more than 7 days.
Control Intervention1: NA: NA
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and Females Adult & Paediatric who are expected to undergo pleural and chest drainages for effective management of Chest Conditions. 2 Subject who can provide Informed Consent Form Adult in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics parent of child LAR Legally Acceptable Representative can provide Informed Assent Form Child. 3 The subject who is willing and able to comply with the requirement of the follow-up OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up.
Exclusion criteria
Exclusion criteria: 1 Subject who present with medical emergency where treatment is more priority than the informed consent informed assent process. 2 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc. 3 Any known allergy with any of the material of Under Water Seal Drainage System Romo Seal and its components. 4 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his her participation in and completion of the clinical investigation plan protocol. 5 Subject who is pregnant or breastfeeding. 6 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 7 Participation in another research study involving an active investigation within 30 days prior to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary End Point of the study are as 1 Clinically intended for Under Water Seal Drainage procedure. 2 Facilitating unrestricted fluid drainage from the pleural cavity. 3 Facilitating the precise drained volume determination. 4 Improving the quality of life of the subject by achieving the intended purpose. Timepoint: Use duration of device is not more than 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary End Point of the study are as 1 Materials Compatibility with the tissue & body fluids. 2 Dedicated Suction port efficacy facilitating regulated suctioning for efficient drainage. 3 Durability Sustainability of Device & fitment of the accessories with standard devices over required period of use. Timepoint: Use duration of device is not more than 7 days. | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed