Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects across different age groups who require postsurgical splinting of the nasal septum and treated with MyNasal Internal Nasal Airway Splints. 2. Subject who has been provided written informed consent. 3. Subject who agreed to undergo all clinical investigations and follow-up visits as per protocol requirements. 4. Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal 5. Subject who required maintaining support healing after nasal surgeries like septoplasty and rhinoplasty, stabilize nasal structures, maintain open airways for better airflow, and facilitate drainage of nasal secretions.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of respiratory tract infection and nasal decongestant use within 1 month before the visit 2. Pregnant or lactating women. 3. Subject with a history of craniocerebral and nasal surgery. 4. Subject any known sensitivity or allergy to silicone or any material used in the splint. 5. Subjects with active nasal infections or untreated chronic sinusitis. 6. Subjects undergoing revision surgery for failed nasal reconstruction. 7. Subjects with coagulopathy or bleeding disorders, or those taking anticoagulant or antiplatelet treatment that may affect with clot formation and wound healing. 8. Subject presents with recent or acute nasal trauma or fractures that necessitate more sophisticated surgical treatments than the splints are insufficient to support the healing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Nasal obstruction 2. Complications and AE/SAE related to device 3. Structural Support and Stability 4. Nasal Airway PatencyTimepoint: 1. Time Frame: Baseline, postoperative, 30 days 7 days, 3 months 15 days 2. Time Frame: Intra-operative, 7 days 2 days, 30 days 7 days, 3 months 15 days 3.Time frame: post-operative, 7 days 2 days, 30 days 2 days 4. Time frame: Pre-operative and post-operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pain and discomfort 2. Nasal airflow 3. Change in Quality of Life 4. Ease of use 5. Removal of Splint timeTimepoint: 1. Time Frame: Baseline, postoperative, 7 days 2 days, 30 days 7 days, 3 months 15 days 2. Time Frame: Post-operative, 7 days 2 days, 30 days 7 days, 3 months 15 days 3.Time Frame: Baseline, 7 days 2 days, 30 days 7 days, 3 months 15 days 4. Time Frame: Intra-operative and 7 days 2 days 5. Time Frame: 7 days 2 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed