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. Subject scheduled for nasal surgery (septoplasty, rhinoplasty, etc.) requiring internal nasal support shall be included. 2. Subjects across different age groups who require post-surgical splinting of the nasal septum and would be treated with MyNasal Internal Nasal Bi-valve Splints. 3. Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form. 4. Subject is willing and able to comply with post-operative scheduled clinical evaluations shall be included. 5. Subject for whom the treating surgeon deems that internal nasal splints are required to maintain nasal patency and prevent septal hematoma, adhesion formation, or collapse post-surgery shall be included.
Exclusion criteria
Exclusion criteria: 1. Subject any known sensitivity or allergy to silicone or any material used in the splint will disqualify a participant from the trial shall be excluded. 2. Subjects with active nasal infections or untreated chronic sinusitis shall be excluded. 3. Subjects undergoing revision surgery for failed nasal reconstruction shall be excluded. 4. Subjects with coagulopathy or bleeding disorders, or those taking anticoagulant or antiplatelet treatment that may affect with clot formation and wound healing will be excluded shall be excluded. 5. 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 and will be excluded shall be excluded. 6. Subjects who have undergone previous nasal surgeries involving the insertion of permanent devices may have difficulty with bi- valve splints. These splints may be difficult to insert or remove due to the presence of such device and shall be excluded. 7. Pregnant women will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Nasal airway patency 2. Structural Support and Stability 3. Bleeding and hematomaTimepoint: 1. Time frame: Pre-operative and postoperative 2. Time frame: Post-operative, 7 days 2 days, 15 days 2 days 3. Time frame: Pre-operative, Postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematoma formation 2. Adhesion formation 3. Visual analog scale 4. Complication and AE/SAE 5. Ease of use 6. Nasal Obstruction Symptom Evaluation (NOSE) 7. Removal of Splint timeTimepoint: 1.Time frame: Post-operative , 7 days 2 days, 15 days 2 days, 30 days 15 days, 3 months 15 days 2. Time Frame: 7 days 2 days, 15 days 2 days, and 30 days 7 days, 3 months 15 days 3.Time Frame: Pre-operative, Postoperative, 7 days 2 days, 15 days 2 days, 30 days 15 days and 3 months 15 days 4. Time Frame: Intra and Post-operative, 7 days 2 days, 15 days 2 days, 30 days 7 days and 3 months 15 days 5. Time Frame: Intra operative, 7 days 2 days, 15 days 2 days 6.Time Frame: Preoperative, Post-operative, 7 days 2 days, 15 days 2 days, 30 days 7 days and 3 months 15 days 7.Time frame: 7 days 2 days to 15 days 2 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed