Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: (1)Thoracic Trocar Catheter – GS-5030.
(2)Chest Drainage Catheter – Straight(GS-5010) / Right Angle (GS-5011A).
(3)Flexo Cath-Straight (GS-5034) / Right Angle (GS-5034A). : Device is si
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and Females (Adult & Pediatric) who are expected to require Thoracic Trocar Catheter. 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 Pediatrics, 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 Pediatrics, 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 with bleeding disorder, extensive malignant skin involvement, multicoated effusions, located fluid accumulations, hepatic hydrothorax. 3. Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Pediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc. 4. Any known allergy with any of the material of Thoracic Trocar Catheter and its component(s). 5. Subject who is pregnant or breast feeding. 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 |
|---|---|
| 1. Quick non-operative pleural, chest drainage for the relief of chest conditions such as tensions pneumothorax. 2. Drainage of air / blood / pus / chyle / other fluids from pleural space. 3. Accomplishment of intended application. 4. Material compatibility with the tissue and body fluids.Timepoint: Device maximum use duration is 5 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fitment with standard devices or under water seal drainage system. 2. Relief of clinical symptoms. Timepoint: Device maximum use duration is 5 days. | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed